The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 8604-fo Pulse Oximeter.
| Device ID | K910001 |
| 510k Number | K910001 |
| Device Name: | MODEL 8604-FO PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 12900 HIGHWAY 55 Minneapolis, MN 55441 |
| Contact | Neal F Nordling |
| Correspondent | Neal F Nordling NONIN MEDICAL, INC. 12900 HIGHWAY 55 Minneapolis, 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 | 1991-01-02 |
| Decision Date | 1991-07-18 |