The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Passport Series Patient Monitors(passport 12m, Passport 17m).
| Device ID | K170876 |
| 510k Number | K170876 |
| Device Name: | Passport Series Patient Monitors(Passport 12m, Passport 17m) |
| 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, TW 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, TW 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 | 2017-03-24 |
| Decision Date | 2017-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904091594 | K170876 | 000 |
| 06944904098494 | K170876 | 000 |
| 06944904098470 | K170876 | 000 |
| 06944904098456 | K170876 | 000 |
| 06944904098449 | K170876 | 000 |
| 06944904098432 | K170876 | 000 |
| 06944904098418 | K170876 | 000 |
| 06944904098395 | K170876 | 000 |
| 06936415905514 | K170876 | 000 |
| 06936415902742 | K170876 | 000 |
| 06944904096803 | K170876 | 000 |
| 06944904098258 | K170876 | 000 |
| 06944904098401 | K170876 | 000 |
| 06944904092850 | K170876 | 000 |
| 06944904098784 | K170876 | 000 |
| 06944904098500 | K170876 | 000 |
| 06944904098166 | K170876 | 000 |
| 06944904096759 | K170876 | 000 |
| 06944904096698 | K170876 | 000 |
| 06944904098807 | K170876 | 000 |
| 06944904098791 | K170876 | 000 |
| 06944904098777 | K170876 | 000 |
| 06936415902636 | K170876 | 000 |