K082846 is an FDA 510(k) clearance for the APK SPO2 PULSE OXIMETER SENSOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by APK Technology Co., Ltd. (No. 2 Road(S); Shanghai, CN). The FDA issued a Cleared decision on April 3, 2009, 186 days after receiving the submission on September 29, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K082846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2008 |
| Decision Date | April 03, 2009 |
| Days to Decision | 186 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 |