K191420 is an FDA 510(k) clearance for the Reusable SpO2 Sensor. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Changke Connect Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 11, 2019, 136 days after receiving the submission on May 28, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K191420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2019 |
| Decision Date | October 11, 2019 |
| Days to Decision | 136 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 |