510(k) K832679
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1984
- Date Received
- August 9, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phonocardiograph
- Device Class
- Class I
- Regulation Number
- 870.2390
- Review Panel
- CV
- Submission Type