RhythmAnalytics
K-Number: K182344 · 2019-03-07
ApplicantBiofourmis Singapore Pte., Ltd.
Decision Date2019-03-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RhythmAnalytics is a medical device manufactured by Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2019-03-07 under approval number K182344. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RhythmAnalytics?
RhythmAnalytics is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Biofourmis Singapore Pte., Ltd.. The 510(k) number is K182344.
When was RhythmAnalytics approved by the FDA?
RhythmAnalytics received FDA 510(k) clearance on 2019-03-07, under approval number K182344.
What company makes RhythmAnalytics?
RhythmAnalytics is manufactured by Biofourmis Singapore Pte., Ltd..
What is the FDA product code for RhythmAnalytics?
The FDA product code for RhythmAnalytics is DQK.
Other Devices by Biofourmis Singapore Pte., Ltd.
Related Devices (Code: DQK)
K160218AutoMark ModuleSt Jude Medical
K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical
K162643MediGuide Technology SystemSt Jude Medical
K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.
K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical
K160186EnSite Velocity Surface Electrode KitSt Jude Medical
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.