K912909 is an FDA 510(k) clearance for the SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM. 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 November 5, 1991, 126 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 | K912909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1991 |
| Decision Date | November 05, 1991 |
| Days to Decision | 126 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 |