Submission Details
| 510(k) Number | K240375 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
V80 Anesthetic Vaporizer (V80)
Oct 2024
Decision
267d
Days
Class 2
Risk
About This 510(k) Submission
K240375 is an FDA 510(k) clearance for the V80 Anesthetic Vaporizer (V80), 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 review panel. Regulated under 21 CFR 868.5880.
Device Classification
| Product Code | CAD — Vaporizer, Anesthesia, Non-heated |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5880 |
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen · CN
Yanhong Bai
154 submissions
154 cleared
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