FDA 510(k)

Rhythm View Workstation (non-streaming)

K-Number: K161240 · 2016-08-10

Decision Date2016-08-10

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Rhythm View Workstation (non-streaming) is a medical device manufactured by Abbott Electrophysiology. It received FDA 510(k) clearance on 2016-08-10 under approval number K161240. 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 Rhythm View Workstation (non-streaming)?

Rhythm View Workstation (non-streaming) is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Abbott Electrophysiology. The 510(k) number is K161240.

When was Rhythm View Workstation (non-streaming) approved by the FDA?

Rhythm View Workstation (non-streaming) received FDA 510(k) clearance on 2016-08-10, under approval number K161240.

What company makes Rhythm View Workstation (non-streaming)?

Rhythm View Workstation (non-streaming) is manufactured by Abbott Electrophysiology.

What is the FDA product code for Rhythm View Workstation (non-streaming)?

The FDA product code for Rhythm View Workstation (non-streaming) is DQK.

Other Devices by Abbott Electrophysiology

K153093FIRMap Catheter K171583RhythmView Workstation 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.