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Medium-Term Adjunctive Predictive Cardiovascular Indicator

FDA product code QNL · 6 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
2021-01-09 – 2026-09-18

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 within a defined medium-term period. 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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