K093306 is an FDA 510(k) clearance for the SINGLE-PATIENT USE DISPOSABLE SENSOR. 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 March 4, 2010, 133 days after receiving the submission on October 22, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K093306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2009 |
| Decision Date | March 04, 2010 |
| Days to Decision | 133 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 |