510(k) K970350
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1997
- Date Received
- January 30, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mattress, Air Flotation, Alternating Pressure
- Device Class
- Class II
- Regulation Number
- 880.5550
- Review Panel
- HO
- Submission Type