510(k) K012492
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2001
- Date Received
- August 3, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dynamometer, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 888.1240
- Review Panel
- NE
- Submission Type