QUO — Adjunctive Heart Failure Status Indicator Class II
Classification Details
- Product Code
- QUO
- Device Class
- Class II
- Regulation Number
- 870.2200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.