FDA device listing
BeneVision N Series Patient Monitors (Including BeneVision M12, BeneVision M12C),BeneVision N Series Patient Monitors…
FDA device listing 1497357508 · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Key facts
| Proprietary names | BeneVision N Series Patient Monitors (Including BeneVision M12 , BeneVision M12C),BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C),BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17),BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17),BeneVision N Series… |
|---|---|
| Owner/operator | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Owner/operator number | 9058402 |
| Premarket submissions | K213799 |
| Product codes | CBQ, CBR, CBS, CCK, CCL, DQA, DRG, DRS, DRT, DSB, DSI, DSJ and 19 more |
| Device names | CBQ - Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), CBR - Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), CBS - Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, CCL - Analyzer, Gas, Oxygen, Gaseous-Phase, DQA - Oximeter, DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency, DRS - Transducer, Blood-Pressure, Extravascular, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSB - Plethysmograph, Impedance, DSI - Detector And Alarm, Arrhythmia, DSJ - Alarm, Blood-Pressure and 19 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.2775, 870.1025, 870.1100, 870.1110, 870.1130, 870.1435, 870.2300 and 9 more |
| Review panels | Anesthesiology, Cardiovascular, General Hospital, Neurology |
| 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
- None 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