K220107 is an FDA 510(k) clearance for the Mindray SV600 Ventilator, Mindray SV800 Ventilator. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 16, 2023, 520 days after receiving the submission on January 12, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K220107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 520 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |