The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Pulse Oximeter.
| Device ID | K191403 |
| 510k Number | K191403 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441 |
| Contact | Walter Holbein |
| Correspondent | Walter Holbein 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 | 2019-05-24 |
| Decision Date | 2019-12-20 |