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Adjunctive Hemodynamic Indicator With Decision Point For Military Use

FDA product code SAR · 1 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
2024-04-05 – 2024-04-05

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. The device is intended for use by the Military.

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