K001085 is an FDA 510(k) clearance for the MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 1, 2000, 27 days after receiving the submission on April 4, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K001085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2000 |
| Decision Date | May 01, 2000 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |