510(k) K972020
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1998
- Date Received
- June 2, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Phonocatheter, Intracavitary
- Device Class
- Class II
- Regulation Number
- 870.1270
- Review Panel
- CV
- Submission Type