K131111 is an FDA 510(k) clearance for the IHEALTH FINGERTIP PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on September 11, 2013, 145 days after receiving the submission on April 19, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K131111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2013 |
| Decision Date | September 11, 2013 |
| Days to Decision | 145 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 |