The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Modification To Onyx, Finger Clip Pulse Oximeter, Model 9500.
| Device ID | K001085 |
| 510k Number | K001085 |
| Device Name: | MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Contact | Richard P Bennett |
| Correspondent | Richard P Bennett NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-05-01 |