K924297 is an FDA 510(k) clearance for the DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER. 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 March 18, 1993, 204 days after receiving the submission on August 26, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K924297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1992 |
| Decision Date | March 18, 1993 |
| Days to Decision | 204 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 |