K960012 is an FDA 510(k) clearance for the STRYKER ADEL BASSINET. This device is classified as a Bed, Pediatric Open Hospital (Class II - Special Controls, product code FMS).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on March 25, 1996, 83 days after receiving the submission on January 2, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5140.
| 510(k) Number | K960012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1996 |
| Decision Date | March 25, 1996 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMS — Bed, Pediatric Open Hospital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5140 |