510(k) K952090
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1995
- Date Received
- May 3, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Isokinetic Testing And Evaluation
- Device Class
- Class II
- Regulation Number
- 890.1925
- Review Panel
- PM
- Submission Type