510(k) K896553
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 1990
- Date Received
- November 17, 1989
- 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