FDA device listing
BioButton Charging Station,BioButton MPU,BioButton Rechargeable,BioButton Rechargeable (BBR),BioButton System…
FDA device listing 1081112677 · BioIntelliSense Inc.
Key facts
| Proprietary names | BioButton Charging Station,BioButton MPU,BioButton Rechargeable,BioButton Rechargeable (BBR),BioButton System (Multi-patient Use or MPU),BioButton v3 |
|---|---|
| Owner/operator | BioIntelliSense Inc. |
| Owner/operator number | 10062701 |
| Premarket submissions | K241101 |
| Product codes | DRG, DRT |
| Device names | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2300, 870.2910 |
| Review panels | Cardiovascular |
| Registered establishments | BIOINTELLISENSE INC. |
| Establishment registrations | 3016592682, 3017986070 |
| FEI numbers | 3016592682, 3017986070 |
| 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