Biotres Pro 1.0
Biotres Pro 1.0 is a Class II device made by Biotricity, Inc., cleared under FDA 510(k) K222017 on 28 Jul 2022 (1 earlier submission) and listed in FDA GUDID since 7 Mar 2024 (UDI-DI B635BIOTRESPR0), 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 | NumberB635BIOTRESPR0 | Date7 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222017 | Date28 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K222017
- FDA 510(k) database K211709
Across registries
- FDA 510(k) K222017 decided 28 Jul 2022 Active
- FDA GUDID UDI-DI B635BIOTRESPR0 listed 7 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K211709
- Cleared FDA 510(k) K222017
- Listed FDA GUDID B635BIOTRESPR0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Biotres Pro
- Generic name
- Electrocardiographic ambulatory recorder
- Model / reference
- 1.0
- Primary DI / UDI-DI
- B635BIOTRESPR0
- FDA product code
- MWJ
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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