510(k) K962377
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1996
- Date Received
- June 20, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Goniometer, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 888.1500
- Review Panel
- NE
- Submission Type