K082546 is an FDA 510(k) clearance for the REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Unimed Medical Supplies, Inc. (Mukwonago, US). The FDA issued a Cleared decision on December 2, 2008, 90 days after receiving the submission on September 3, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K082546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2008 |
| Decision Date | December 02, 2008 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |