510(k) K950537
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1996
- Date Received
- February 7, 1995
- 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