510(k) K812778
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1981
- Date Received
- October 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Goniometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1520
- Review Panel
- NE
- Submission Type