The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Regional Oximeter.
| Device ID | K102715 |
| 510k Number | K102715 |
| Device Name: | REGIONAL OXIMETER |
| Classification | Oximeter, Tissue Saturation |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori M Mitchell |
| Correspondent | Lori M Mitchell 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 | 2010-09-20 |
| Decision Date | 2010-12-17 |
| Summary: | summary |