K150167 is an FDA 510(k) clearance for the V60 Anesthetic Vaporizer. 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 June 30, 2015, 155 days after receiving the submission on January 26, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.
| 510(k) Number | K150167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | CAD — Vaporizer, Anesthesia, Non-heated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5880 |