FDA device listing
Arm-Type Electronic Blood Pressure Monitor Moderl BSX5011,Arm-Type Electronic Blood Pressure Monitor Moderl…
FDA device listing 1252847615 · Shenzhen BSX Technology Electronics Co.,Ltd
Key facts
| Proprietary names | Arm-Type Electronic Blood Pressure Monitor Moderl BSX5011,Arm-Type Electronic Blood Pressure Monitor Moderl BSX5021,Arm-Type Electronic Blood Pressure Monitor Moderl BSX5035,Arm-Type Electronic Blood Pressure Monitor Moderl BSX505,Arm-Type Electronic Blood Pressure Monitor Moderl BSX5113,Arm-Type Electronic Blood Pressure Monitor Moderl BSX5125,Arm-Type Electronic Blood Pressure Monitor Moderl… |
|---|---|
| Owner/operator | Shenzhen BSX Technology Electronics Co.,Ltd |
| Owner/operator number | 10060909 |
| Premarket submissions | K183058 |
| 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 BSX TECHNOLOGY ELECTRONICS CO.,LTD |
| Establishment registrations | 3015542362 |
| FEI numbers | 3015542362 |
| Establishment operations | 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