510(k) K971407
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1998
- Date Received
- April 16, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dynamometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1250
- Review Panel
- NE
- Submission Type