K182977 is an FDA 510(k) clearance for the Isolette 8000 Plus. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 21, 2018, 26 days after receiving the submission on October 26, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K182977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2018 |
| Decision Date | November 21, 2018 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |