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FDA 510(k), K182344, RhythmAnalytics
FDA 510(k), K182344, RhythmAnalytics
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510(K) Number: K182344
Device Name: RhythmAnalytics
Manufacturer: Biofourmis Singapore Pte. Ltd.
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 08/28/2018
Decision Date: 03/07/2019
Regulation Medical Specialty: Cardiovascular
Device Name: RhythmAnalytics
Manufacturer: Biofourmis Singapore Pte. Ltd.
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 08/28/2018
Decision Date: 03/07/2019
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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