(107 days)
The Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
For the EW 3037, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure", U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure.
The EW 3037 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
Panasonic Wrist Blood Pressure Monitor Models EW3003 and EW3037
This looks like a 510(k) clearance letter for the Panasonic Wrist Blood Pressure Monitor, Models EW3003 and EW3037. While it states that the device is substantially equivalent to a predicate device and permits marketing, it does not contain the detailed study information required to answer your questions about acceptance criteria and device performance studies.
The provided document is a regulatory clearance, not a summary of the clinical or performance studies themselves. To get the information you're looking for, you would typically need to consult the original 510(k) submission document or related published studies, which are not included here.
Therefore, I cannot provide the requested information based solely on the text provided.
If you can provide the actual 510(k) submission document or a summary of the performance testing, I would be able to extract the details you're asking for.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).