510(k) K941033
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1995
- Date Received
- March 4, 1994
- 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