Bioflux 1.0
by Biotricity, Inc. 2 variants
Bioflux 1.0 is a Class II device made by Biotricity, Inc., cleared under FDA 510(k) K172311 on 15 Dec 2017 and listed in FDA GUDID since 31 Aug 2022 (UDI-DI B635BIOFLUX1A0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB635BIOFLUX1A0 | Date31 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172311 | Date15 Dec 2017 | StatusActive |
Official records
- FDA 510(k) database K172311
Across registries
- FDA 510(k) K172311 decided 15 Dec 2017 Active
- FDA GUDID UDI-DI B635BIOFLUX1A0 listed 31 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K172311
- Listed FDA GUDID B635BIOFLUX1A0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bioflux
- Generic name
- Electrocardiography telemetric monitoring system transmitter
- Model / reference
- 1.0
- Primary DI / UDI-DI
- B635BIOFLUX1A0
- 510(k) Number
- FDA product code
- DXH
- GMDN term
- Electrocardiography telemetric monitoring system transmitter
- Device class
- Class II
- Regulation number
- 870.2920
- GUDID distribution status
- In Commercial Distribution
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