FDA 510(k)

RhythmView Workstation

K-Number: K171583 · 2017-09-01

Decision Date2017-09-01

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RhythmView Workstation is a medical device manufactured by Abbott Electrophysiology. It received FDA 510(k) clearance on 2017-09-01 under approval number K171583. 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 RhythmView Workstation?

RhythmView Workstation is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Abbott Electrophysiology. The 510(k) number is K171583.

When was RhythmView Workstation approved by the FDA?

RhythmView Workstation received FDA 510(k) clearance on 2017-09-01, under approval number K171583.

What company makes RhythmView Workstation?

RhythmView Workstation is manufactured by Abbott Electrophysiology.

What is the FDA product code for RhythmView Workstation?

The FDA product code for RhythmView Workstation is DQK.

Other Devices by Abbott Electrophysiology

K161240Rhythm View Workstation (non-streaming) K153093FIRMap Catheter K163709FIRMap Catheter

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.