The CONNEQT PULSE is a non-invasive blood pressure measurement system designed to provide derived ascending aortic blood pressure waveforms and a range of central arterial indices. It automatically measures brachial systolic and diastolic blood pressures and heart rate, with a measurement range of 8.6″-12.6″ and 12.6″-16.5″ cuff circumference.
Indications for Use: The device is intended for prescription use (21 CFR 801 Subpart D) and over-the-counter use (21 CFR 801 Subpart C).
Device Information:
The CONNEQT PULSE is classified as a Non-Invasive Blood Pressure Measurement System, with a product code of DXN, DSK and a regulation number of 21 CFR 870.1130, 21 CFR 870.1110.
Classification:
The device is classified as a Class II medical device by the FDA, and is substantially equivalent to the primary predicate device, SphygmoCor XCEL (K122129), and the reference predicate device, iHealth Wireless Blood Pressure Monitor (K162144).
Manual:
Download: FDA 510(k) Summary for CONNEQT PULSE Non-Invasive Blood Pressure Measurement System
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