K172981 is an FDA 510(k) clearance for the Reusable SpO2 Sensors, Disposable SpO2 Sensors. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by APK Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 8, 2018, 254 days after receiving the submission on September 27, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K172981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2017 |
| Decision Date | June 08, 2018 |
| Days to Decision | 254 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 |