Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153448
Passport Series Patient Monitors (Including Passport 8, Passport 12) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · decided 2016-03-03 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| BP_CO_AG Module(with 02)(FDA/FJ/PK.) | 115-030784-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086125 |
| IBP module(FDA/FJ/PK..) | 115-030780-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086088 |
| Patient Monitor Passport 8 | Passport 8 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904085692 |
| IBP_CO_SidestreamCO2 module(FDA/FJ/PK.) | 115-030782-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086101 |
| Cardiac Output Cable (12Pin) | 0010-30-42743 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904004631 |
| Sidestream CO2 module(FDA/PK.) | 115-030773-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086019 |
| IBP_CO_SidestreamCO2 module(FDA/PK.) | 115-030776-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086040 |
| IBP_CO_AG Module(with 02)(FDA/PK.) | 115-030778-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904090900 |
| IBP module(FDA/PK.) | 115-030774-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086026 |
| IBP_CO_MicrostreamCO2 module(FDA/FJ/PK.) | 115-030783-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086118 |
| KIT,MICROSTREAM,T5/T8,DPM6/7 | 6800-30-50619 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904006475 |
| IBP_CO module(FDA/FJ/PK.) | 115-030781-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086095 |
| Patient Monitor Passport 12 | Passport 12 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904085708 |
| IBP_CO_MicrostreamCO2module(FDA/PK.) | 115-030777-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904090917 |
| IBP_CO module(FDA/PK.) | 115-030775-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086033 |
| Sidestream CO2 module(FDA/FJ/PK.) | 115-030779-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | 06944904086071 |