The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Regional Oximeter System, Model 7600.
| Device ID | K090807 |
| 510k Number | K090807 |
| Device Name: | REGIONAL OXIMETER SYSTEM, MODEL 7600 |
| Classification | Oximeter, Tissue Saturation |
| 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 | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849686071405 | K090807 | 000 |
| 00833166007619 | K090807 | 000 |
| 00833166009743 | K090807 | 000 |
| 00849686070682 | K090807 | 000 |
| 00849686071412 | K090807 | 000 |
| 00849686067606 | K090807 | 000 |
| 00833166002850 | K090807 | 000 |
| 00833166007688 | K090807 | 000 |
| 00849686070699 | K090807 | 000 |
| 00849686085808 | K090807 | 000 |
| 00849686088786 | K090807 | 000 |