K192404 is an FDA 510(k) clearance for the Patient Monitoring Cable (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 Shenzhen Coreray Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 22, 2020, 293 days after receiving the submission on September 3, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K192404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | June 22, 2020 |
| Days to Decision | 293 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 |