The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for V Series Monitoring System (including V12 And V21 Monitors).
| Device ID | K150352 |
| 510k Number | K150352 |
| Device Name: | V Series Monitoring System (including V12 And V21 Monitors) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, CN 518057 |
| Contact | Yanhong Bai |
| Correspondent | Yanhong Bai SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, CN 518057 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-09-02 |
| Summary: | summary |