510(k) K871557
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1987
- Date Received
- April 22, 1987
- 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