K040589 is an FDA 510(k) clearance for the MODIFICATION TO AVANT 9600 PULSE OXIMETER. 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 June 3, 2004, 87 days after receiving the submission on March 8, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K040589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2004 |
| Decision Date | June 03, 2004 |
| Days to Decision | 87 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 |