The following data is part of a premarket notification filed by Cosmed Nordic Aps with the FDA for Nicu V'02.
| Device ID | K190561 |
| 510k Number | K190561 |
| Device Name: | NICU V'02 |
| Classification | Computer, Oxygen-uptake |
| Applicant | COSMED Nordic ApS Lucernemarken 23 Odense, DK Dk-5260 |
| Contact | Peter Clemensen |
| Correspondent | H. Carl Jenkins Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, IL 60044 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2020-09-04 |