K190494 is an FDA 510(k) clearance for the Infant Incubator. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Ningbo David Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on November 25, 2019, 270 days after receiving the submission on February 28, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K190494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2019 |
| Decision Date | November 25, 2019 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMZ - Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |