Search Results

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888JF

This document is a 510(k) premarket notification approval letter for the HL888JF Non-invasive Blood Pressure Measurement System. It is an approval letter and does not contain detailed information about acceptance criteria or the specific study details that would prove a device meets acceptance criteria.

The letter acknowledges that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device meets the regulatory requirements for safety and effectiveness similar to already approved devices, but the letter does not present the specific acceptance criteria or the detailed study results used for that determination.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory approval and classification of the device rather than the technical details of its performance testing.

Ask a specific question about this device