K912910 is an FDA 510(k) clearance for the C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on October 30, 1991, 120 days after receiving the submission on July 2, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K912910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1991 |
| Decision Date | October 30, 1991 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMZ — Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |