RhythmAnalytics 1.1
by Biofourmis Singapore Pte., Ltd.
RhythmAnalytics 1.1 is a Class II device made by Biofourmis Singapore Pte., Ltd., cleared under FDA 510(k) K182344 on 7 Mar 2019 and listed in FDA GUDID since 28 Oct 2022 (UDI-DI 08885018690014), 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 | Number08885018690014 | Date28 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182344 | Date7 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 08885018690014
- FDA 510(k) database K182344
Across registries
- FDA 510(k) K182344 decided 7 Mar 2019 Active
- FDA GUDID UDI-DI 08885018690014 listed 28 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K182344
- Listed FDA GUDID 08885018690014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RhythmAnalytics
- Generic name
- Cardiopulmonary physiological parameter analysis software, professional-only
- Model / reference
- 1.1
- Primary DI / UDI-DI
- 08885018690014
- 510(k) Number
- FDA product code
- DQK, DPS
- GMDN term
- Cardiopulmonary physiological parameter analysis software, professional-only
- Device class
- Class II
- Regulation number
- 870.1425, 870.2340
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Cardiopulmonary physiological parameter analysis software.