K222370 is an FDA 510(k) clearance for the SpO2 Extension Cable. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Beijing Rongrui-Century Science & Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 2, 2023, 240 days after receiving the submission on August 5, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K222370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2022 |
| Decision Date | April 02, 2023 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DSA - Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |