The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model X-100c Co-met™ Oximetry System.
| Device ID | K160231 |
| 510k Number | K160231 |
| Device Name: | Model X-100C CO-Met™ Oximetry System |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVENUE NORTH Plymouth, MN 55441 |
| Contact | Kim E. Aves |
| Correspondent | Kim E. Aves NONIN MEDICAL, INC. 13700 1ST AVENUE NORTH Plymouth, MN 55441 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-12-23 |
| Summary: | summary |