K111617 is an FDA 510(k) clearance for the PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Acare Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 22, 2011, 195 days after receiving the submission on June 10, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K111617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2011 |
| Decision Date | December 22, 2011 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |