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Adjunctive Predictive Cardiovascular Indicator

FDA product code QAQ · 4 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2210
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-05-21 – 2025-05-15

The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

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