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Adjunctive Heart Failure Status Indicator

FDA product code QUO · 4 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2200
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-11-23 – 2025-11-21

The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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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