Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K170876
Passport Series Patient Monitors(Passport 12m, Passport 17m) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · decided 2017-08-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| IBP_CO_AG Module(with 02)(FDA)II | 115-050570-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098470 |
| SMR material package(2M/handle/hook) | 115-046944-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098777 |
| Sidestream CO2 module(FDA/FJ)II | 115-050571-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904098432 |
| BIS module kit(Package/no accessory) | 115-048957-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098494 |
| NMT module (accessory kit) | 115-044873-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | KOI | 06944904098166 |
| 8pin masimo Cable | 040-003310-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904092850 |
| 1-Slot CO2 Module w/ kit (Adult/Ped) | 115-049134-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCK | 06936415902742 |
| SMR material package(2M/no handle) | 115-046949-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098258 |
| single CO2 Module(accessory kit) | 115-046938-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904096698 |
| NMT Module (Package/no accessory) | 115-044872-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | KOI | 06944904098500 |
| Bedrail hook TDS handle | 115-046940-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098401 |
| 115-046935-00 | CO2 module,M02C | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904098784 |
| IBP_CO_SidestreamCO2 module(FDA)II | 115-050569-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904098449 |
| IBP_CO_SidestreamCO2 module(FDA/FJ)II | 115-050572-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904098456 |
| IBP_CO_AG Module(with 02)(FDA/FJ)II | 115-050573-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098395 |
| 1ed Hook Material Package(international) | 115-048990-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098418 |
| CO2 adapter | 045-003134-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904091594 |
| ORIDION CO2 mod upgrd kit,intl | 115-046966-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904096803 |
| vacant module | 115-046897-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098791 |
| ORIDION CO2(Package/no accessory) | 115-046928-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCJ | 06944904096759 |
| 1-Slot CO2/O2 Module w/ kit (Adult/Ped) | 115-049136-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CCK | 06936415902636 |
| SMR material package(10M/handle/hook) | 115-046945-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904098807 |
| NMT Module w/ kit | 115-053717-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | KOI | 06936415905514 |