The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for V60 Anesthetic Vaporizer.
| Device ID | K150167 |
| 510k Number | K150167 |
| Device Name: | V60 Anesthetic Vaporizer |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, P.r. China, CN 518057 |
| Contact | Tang Ho |
| Correspondent | Tang Ho SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, P.r. China, CN 518057 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-06-30 |
| Summary: | summary |