Search Results

Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a blood pressure monitor. It does not contain the detailed acceptance criteria or the study information typically found in a clinical study report or a more comprehensive technical document.

This letter primarily focuses on the FDA's "substantial equivalence" determination, indicating that the device is similar enough to previously approved devices that it doesn't require a new Premarket Approval (PMA) application. It doesn't elaborate on the specific performance metrics or the studies conducted to demonstrate those metrics.

Therefore, I cannot provide the requested information from the provided text.

To answer your request, I would need a different type of document, such as:

• A clinical study report (CSR) for the device.
• A technical specifications document or performance evaluation report submitted as part of the 510(k) application (which is usually much more detailed than the FDA's response letter).
• The specific section of the 510(k) submission that details the device's performance testing.

Ask a specific question about this device