FDA AI Clearance Tracker/K182344
Cardiovascular · 510(k)
RhythmAnalytics
Biofourmis Singapore Pte. Ltd.
About this listing
RhythmAnalytics from Biofourmis Singapore Pte. Ltd. appears on the U.S. FDA list of AI-enabled medical devices under submission K182344. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated March 7, 2019. Its primary FDA product code is DQK.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- RhythmAnalytics
- Company
- Biofourmis Singapore Pte. Ltd.
- Submission number
- K182344
- Pathway
- 510(k)
- Decision date
- Mar 7, 2019
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- DQK
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.