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Adjunctive Hemodynamic Indicator With Decision Point

FDA product code QNV · 2 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2220
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-12-03 – 2022-07-14

An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.

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