K012706 is an FDA 510(k) clearance for the IM2001 PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Imagyn Medical Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on March 7, 2003, 570 days after receiving the submission on August 14, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K012706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2001 |
| Decision Date | March 07, 2003 |
| Days to Decision | 570 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 |