510(k) K904823
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1991
- Date Received
- October 25, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Measuring
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type