The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Wristox Model 3100 Pulse Oximeter.
| Device ID | K052829 |
| 510k Number | K052829 |
| Device Name: | WRISTOX MODEL 3100 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori Roth |
| Correspondent | Lori 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-05 |
| Decision Date | 2005-11-10 |
| Summary: | summary |