The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Pulse Oximeter.
| Device ID | K140785 |
| 510k Number | K140785 |
| Device Name: | PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE, NORTH Plymouth, MN 55441 |
| Contact | Brodie Pedersen |
| Correspondent | Brodie Pedersen NONIN MEDICAL, INC. 13700 1ST AVE, 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 | 2014-03-31 |
| Decision Date | 2014-07-07 |
| Summary: | summary |