510(k) K960012
K960012 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER ADEL BASSINET". The FDA issued a decision of Substantially Equivalent on March 25, 1996. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1996
- Date Received
- January 2, 1996
- 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