The following data is part of a premarket notification filed by Nonin Medical Inc. with the FDA for Reusable, Finger Clip Nonin Medical Co-met Oximetry Sensor.
| Device ID | K172625 |
| 510k Number | K172625 |
| Device Name: | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor |
| 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 | 2017-09-01 |
| Decision Date | 2018-05-11 |
| Summary: | summary |