The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Digital Pulse Oximeter, Model 7500.
| Device ID | K071285 |
| 510k Number | K071285 |
| Device Name: | DIGITAL PULSE OXIMETER, MODEL 7500 |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori M Roth |
| Correspondent | Lori M Roth NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752161368 | K071285 | 000 |