FDA product code QUO

Adjunctive Heart Failure Status Indicator

Cardiovascular·Class 2·21 CFR 870.2200
US regulatory classifications
US Product Code (FDA)
QUO
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2200
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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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About this record

Adjunctive Heart Failure Status Indicator is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.