K173368 is an FDA 510(k) clearance for the Reusable & Disposable SpO2 Sensors. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Coreray Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 31, 2018, 309 days after receiving the submission on October 26, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K173368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2017 |
| Decision Date | August 31, 2018 |
| Days to Decision | 309 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 |