FDA device listing
ARM-30A+,ARM-30G2, ARM-30Q,ARM-30E+,ARM-3010,ARM-3011,ARM-3012,ARM-3013,ARM-3110, ARM-3040,ARM-30V,ARM-30W,SBM 15,Arm…
FDA device listing 1903820414 · Shenzhen AOJ Medical Technology Co., Ltd.
Key facts
| Proprietary names | ARM-30A+,ARM-30G2, ARM-30Q,ARM-30E+,ARM-3010,ARM-3011,ARM-3012,ARM-3013,ARM-3110, ARM-3040,ARM-30V,ARM-30W,SBM 15,Arm Blood Pressure Monitor, ARM-30G+, ARM-30M,ARM-30S,ARM-30T,ARM-HA101, BU 550,BU 518,ARM-30U,ARM-3030,ARM-30Y,BU 520,ARM-3120,ARM-3020,ARM-3021, ARM-3022,ARM-3023,ARM-3080,PRESSURE XS PRO, PRESSURE 9S PRO, XS Pro, 9S Pro |
|---|---|
| Owner/operator | Shenzhen AOJ Medical Technology Co., Ltd. |
| Owner/operator number | 10059056 |
| Premarket submissions | K244000 |
| Product codes | DXN |
| Device names | DXN - System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130 |
| Review panels | Cardiovascular |
| Registered establishments | Shenzhen AOJ Medical Technology Co., Ltd., TELSTAR VIETNAM COMPANY LIMITED |
| Establishment registrations | 3009551875, 3020848330 |
| FEI numbers | 3009551875, 3020848330 |
| Establishment operations | Contract Manufacturer, 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