510(k) K941610
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1995
- Date Received
- March 31, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Flotation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 890.5170
- Review Panel
- PM
- Submission Type