510(k) K813226
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1981
- Date Received
- November 10, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mattress, Flotation Therapy, Non-Powered
- Device Class
- Class I
- Regulation Number
- 880.5150
- Review Panel
- HO
- Submission Type