FDA device listing
Vital Signs Monitors(Including VS 9, VS 8, VS 8A)
FDA device listing 1304229916 · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Key facts
| Proprietary names | Vital Signs Monitors(Including VS 9, VS 8, VS 8A) |
|---|---|
| Owner/operator | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Owner/operator number | 9058402 |
| Premarket submissions | K211475 |
| Product codes | CCK, DQA, DXN, FLL, MWI |
| Device names | CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DQA - Oximeter, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 870.1130, 870.2300, 870.2700, 880.2910 |
| Review panels | Anesthesiology, 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 | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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