The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Umec Series Patient Monitors (including Umec6, Umec7, Umec10, Umec12, Umec15, Umec15s).
| Device ID | K171901 |
| 510k Number | K171901 |
| Device Name: | UMEC Series Patient Monitors (including UMEC6, UMEC7, UMEC10, UMEC12, UMEC15, UMEC15S) |
| 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 | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRS |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| 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 | 2017-06-26 |
| Decision Date | 2017-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415927455 | K171901 | 000 |
| 06936415927448 | K171901 | 000 |
| 06936415919290 | K171901 | 000 |
| 06936415919283 | K171901 | 000 |
| 06936415912406 | K171901 | 000 |
| 06936415900175 | K171901 | 000 |