Submission Details
| 510(k) Number | K150167 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 2015 |
| Decision Date | June 30, 2015 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
V60 Anesthetic Vaporizer
Jun 2015
Decision
155d
Days
Class 2
Risk
About This 510(k) Submission
K150167 is an FDA 510(k) clearance for the V60 Anesthetic Vaporizer, 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 June 30, 2015, 155 days after receiving the submission on January 26, 2015. 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
TANG HO
154 submissions
154 cleared
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