Submission Details
| 510(k) Number | K082546 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
Dec 2008
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
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), 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 review panel. Regulated under 21 CFR 870.2700.
Device Classification
| Product Code | DQA — Oximeter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
Manufacturer
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