Device |
adjunctive heart failure status indicator |
Regulation Description |
Adjunctive cardiovascular status indicator. |
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. |
Product Code | QUO |
Regulation Number |
870.2200
|
Device Class |
2
|
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