Pulse Oximeter with Neck/Wrist + Carrying Bag + Battery We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. We are Foscam Digital Technologies LLC (Foscam US) and sell only 100% genuine medical supply products. If you have any questions please do not hesitate to contact the Manufacturer or us directly. All of our medical supply products ship from within the United States. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If the item is subject to FDA regulation, we can verify your status as an authorized purchaser of this item before shipping of the item. If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health: http://www.fda.gov/cdrh/devadvice/ Http://www.fda.gov/cdrh/industry/support/index.html Phone number: 800.638.2041 Thank you for your cooperation. This portable Fingertip Pulse Oximeter and Heart Rate Monitor is a battery operated medical electronics device that measures your SPo2 and heart rate PM and displays it on the built-in LED display screen for easy viewing. The Fingertip Pulse Oximeter and Heart Rate Monitor measures the saturated level of oxygen in your blood using photoplethysmography, and measures your heart beat per minute by optically obtained plethysmograph which illuminates the skin and measures changes in light absorption. How does it work? To use this health gadget you just insert your finger then press the power button and the Finger Pulse Oximeter and Heart Rate Monitor will display your heart beat p/m, the percentage of oxygen in your blood and also displays an indicator bar that increases and decreases by syncing with the rhythm of your heart beat. The bar graph serves the purpose of letting you know if you’ve got a weak or strong hear based on the level of the graph. You get all this without needing to go to the hospital, see a doctor or have any invasive procedure. This Pulse Oximeter and Heart Rate Monitor is suitable for physicians, home doctors (mom), medical students, healthcare workers, athletes, pilots, community sports centers etc. Demand for a lightweight, inexpensive monitor for measuring SPO2 oxygen saturation and heart rate during physically active sports and high-altitude activities is in huge demand, so we present this Pulse Oximeter and Heart Rate Monitor at a wholesale price and directly available to both home users and medical clinics alike. Product Specifications Description of Product: Finger Pulse Oximeter and Heart Rate Monitor Color: Blue External Material: Hard Molded ABS Plastic Display Mode: LED display SPO2: 35 - 99% Pulse Ratio: 30 - 250 BPM Resolution: 1% for SPO2, 1 BPM for pulse rate Power Requirements: Two AAA alkaline batteries (included) Optical Sensor: Red Light wavelength 660nm, Infrared wavelength 880nm Dimensions: L:58 x W:32 x H: 34 (mm) Certification: FDA CE, FCC, RoHs Product Notes Compact size, light, and convenient to carry SPO2 and PR display, and bar graph display Power off automatically when not used after 10 seconds to save battery power Integrated with SPO2 probe and processing display module This finger pulse oximeter will not monitor SPO2 during active movement. You must stop the your current activity and take the reading while in a stationary position. Package Contents 1 x Pulse Oximeter and Heart Rate Monitor 1 x Carrying bag 1 x Lanyard 1 x User Manual - English 2 x AA 1.5V alkaline batteries Pulse Oximeter Finger Pulse Blood Oxygen SpO2 Monitor had U.S. FDA, FCC, CE, ROHS approved. General Description: The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the 02 concentration in the blood. It is an important bio-parameter for the respiration. Many of the respiration disease will cause hypoxemia, even damage the patient' s life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional method to measure SpO2 is to analyze the sample of the patient' s blood to get the partial pressure of oxygen and calculate the SpO2 by use the blood-gas analyzer. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Pulse Oximeter. The device can measure the pulse rate simultaneously. The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%. The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological products The proposed devices, Fingertip Pulse Oximeter, CMS-50D, CMS-50L and CMS-50DL are modification device to Fingertip Pulse Oximeter, CMS-50C which was cleared in K073454. The proposed devices have same intended use, same design and working principle, same key components (including led, photo detector and medical silicon cushion), same data process module and same specifications with the predicate device. The modifications mainly concern on the display function of the device. Every buyer gets a MyStoreRewards invitation for cash back On Dec-01-14 at 08:32:55 PST, seller added the following information: On Dec-01-14 at 09:55:18 PST, seller added the following information:
By clicking "Accept All Cookies", you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.
