FDA device listing
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
FDA device listing 1789717880 · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Key facts
| Proprietary names | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) |
|---|---|
| Owner/operator | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Owner/operator number | 9058402 |
| Premarket submissions | K190011 |
| Product codes | DQA, DRT, DSI, DSK, DXN, FLL, MHX, MLD |
| Device names | DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSI - Detector And Alarm, Arrhythmia, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), MLD - Monitor, St Segment With Alarm |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.1110, 870.1130, 870.2300, 870.2700, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | Shenzhen Mindray Bio-Medical Electronics Co.,LTD, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
| Establishment registrations | 3007603826, 3009156722 |
| FEI numbers | 3007603826, 3009156722 |
| Establishment operations | Foreign Exporter, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database