K190561 is an FDA 510(k) clearance for the NICU V'02. This device is classified as a Computer, Oxygen-uptake (Class II - Special Controls, product code BZL).
Submitted by Cosmed Nordic Aps (Odense, DK). The FDA issued a Cleared decision on September 4, 2020, 549 days after receiving the submission on March 5, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1730.
| 510(k) Number | K190561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2019 |
| Decision Date | September 04, 2020 |
| Days to Decision | 549 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZL - Computer, Oxygen-uptake |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1730 |