JOO · Transducer, Heart Sound
Cardiovascular · 21 CFR 870.2860 · Class 2
Overview
| Product Code | JOO |
|---|---|
| Device Name | Transducer, Heart Sound |
| Regulation | 21 CFR 870.2860 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
