K240375 is an FDA 510(k) clearance for the V80 Anesthetic Vaporizer (V80). This device is classified as a Vaporizer, Anesthesia, Non-heated (Class II - Special Controls, product code CAD).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 31, 2024, 267 days after receiving the submission on February 7, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.
| 510(k) Number | K240375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2024 |
| Decision Date | October 31, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAD — Vaporizer, Anesthesia, Non-heated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5880 |