510(k) K970334
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1997
- Date Received
- January 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Pediatric Open Hospital
- Device Class
- Class II
- Regulation Number
- 880.5140
- Review Panel
- HO
- Submission Type