FDA device listing
A7 Anesthesia System
FDA device listing 1260527778 · Mindray DS USA, Inc.
Key facts
| Proprietary names | A7 Anesthesia System |
|---|---|
| Owner/operator | Mindray DS USA, Inc. |
| Owner/operator number | 10025908 |
| Premarket submissions | K171292 |
| Product codes | BSZ, CBQ, CBR, CBS, CCK, CCL, KDP, NHO, NHP, NHQ |
| Device names | BSZ - Gas-Machine, Anesthesia, 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, KDP - Regulator, Vacuum, NHO - Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration), NHP - Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration), NHQ - Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.5160, 880.6740 |
| Review panels | Anesthesiology, General Hospital |
| Registered establishments | MINDRAY DS USA, Inc. |
| Establishment registrations | 2221819 |
| FEI numbers | 2221819 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer |
| 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