FDA device listing
BPBIO320,BPBIO320n,BPBIO 320 S,BPBIO 320 SN,BPBIO 330 S,BPBIO 330 SN,BPBIO680KV,BPBIO 750,BPBIO780KV
FDA device listing 1740845449 · InBody Co. Ltd.
Key facts
| Proprietary names | BPBIO320,BPBIO320n,BPBIO 320 S,BPBIO 320 SN,BPBIO 330 S,BPBIO 330 SN,BPBIO680KV,BPBIO 750,BPBIO780KV |
|---|---|
| Owner/operator | InBody Co. Ltd. |
| Owner/operator number | 9041413 |
| Premarket submissions | K131064 |
| 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 | BIOSPACE INC., InBody Co, Ltd., InBody Factory #2, |
| Establishment registrations | 3003074886, 3003193933, 3022764531 |
| FEI numbers | 3003074886, 3003193933, 3022764531 |
| Establishment operations | Complaint File Establishment, 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