510(k) K952369
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1995
- Date Received
- May 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Powered
- Device Class
- Class I
- Regulation Number
- 890.5380
- Review Panel
- PM
- Submission Type