Patient Monitor
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Shenzhen Mindray Bio-medical Electronics Co., LTD.
The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Patient Monitor.
Pre-market Notification Details
| Device ID | K192972 |
| 510k Number | K192972 |
| Device Name: | Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road 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 Road SoutH Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-24 |
| Decision Date | 2020-05-07 |
Trademark Results [Patient Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |
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