The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 7600 Regional Oximeter System With Equanox Technology.
| Device ID | K113215 |
| 510k Number | K113215 |
| Device Name: | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY |
| Classification | Oximeter, Tissue Saturation |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE, NORTH Plymouth, MN 55441 |
| Contact | Brodie Pederson |
| Correspondent | Brodie Pederson NONIN MEDICAL, INC. 13700 1ST AVE, NORTH Plymouth, MN 55441 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2012-05-14 |
| Summary: | summary |