510(k) K840551
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1984
- Date Received
- February 8, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Non-Measuring
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type