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FDA 510(k)

EP-WORKMATE SYSTEM, VERSION 4.2

K-Number: K092810 · 2009-10-09

ApplicantSt Jude Medical
Decision Date2009-10-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP-WORKMATE SYSTEM, VERSION 4.2 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092810. 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 EP-WORKMATE SYSTEM, VERSION 4.2?

EP-WORKMATE SYSTEM, VERSION 4.2 is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is St Jude Medical. The 510(k) number is K092810.

When did EP-WORKMATE SYSTEM, VERSION 4.2 receive FDA 510(k) clearance?

EP-WORKMATE SYSTEM, VERSION 4.2 received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092810.

Who is the listed applicant for EP-WORKMATE SYSTEM, VERSION 4.2?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EP-WORKMATE SYSTEM, VERSION 4.2?

The FDA product code for EP-WORKMATE SYSTEM, VERSION 4.2 is DQK.

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Related Devices (Code: DQK)

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K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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.

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