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FDA 510(k)

EP-WORKMATE

K-Number: K063113 · 2006-10-27

ApplicantEp Medsystems
Decision Date2006-10-27
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP-WORKMATE is the device name listed in this FDA 510(k) record. The listed applicant is Ep Medsystems. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K063113. 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?

EP-WORKMATE is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Ep Medsystems. The 510(k) number is K063113.

When did EP-WORKMATE receive FDA 510(k) clearance?

EP-WORKMATE received FDA 510(k) clearance on 2006-10-27, under 510(k) number K063113.

Who is the listed applicant for EP-WORKMATE?

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

What is the FDA product code for EP-WORKMATE?

The FDA product code for EP-WORKMATE is DQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ep Medsystems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04K073709MODIFICATION TO VIEWMATE SYSTEMK071028VIEWMATE SYSTEMK070706EP-WORKMATEK041442EP-4 CLINICAL STIMUTATORK040207EP-4 CLINICAL STIMULATOR

View all 12 devices →

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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