K162821 is an FDA 510(k) clearance for the Babyleo TN500. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Draegerwerk AG & CO Kgaa (Lübeck, DE). The FDA issued a Cleared decision on June 23, 2017, 259 days after receiving the submission on October 7, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K162821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2016 |
| Decision Date | June 23, 2017 |
| Days to Decision | 259 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 |