The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Onyx Ii Finger Pulse Oximeter, Model 9550.
| Device ID | K053130 |
| 510k Number | K053130 |
| Device Name: | ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-08 |
| Decision Date | 2006-01-11 |
| Summary: | summary |