The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Epm Series Patient Monitors.
| Device ID | K191769 |
| 510k Number | K191769 |
| Device Name: | EPM Series Patient Monitors |
| 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 | 2019-07-01 |
| Decision Date | 2019-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904003948 | K191769 | 000 |
| 06944904003931 | K191769 | 000 |
| 06944904003924 | K191769 | 000 |
| 06944904003917 | K191769 | 000 |
| 06944904003900 | K191769 | 000 |
| 06936415904098 | K191769 | 000 |
| 06936415904081 | K191769 | 000 |