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FDA 510(k)

EP-WORKMATE WITH RPM SYSTEM

K-Number: K032225 · 2003-08-20

ApplicantEp Medsystems
Decision Date2003-08-20
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP-WORKMATE WITH RPM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ep Medsystems. It received FDA 510(k) clearance on 2003-08-20 under 510(k) number K032225. 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 WITH RPM SYSTEM?

EP-WORKMATE WITH RPM SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Ep Medsystems. The 510(k) number is K032225.

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

EP-WORKMATE WITH RPM SYSTEM received FDA 510(k) clearance on 2003-08-20, under 510(k) number K032225.

Who is the listed applicant for EP-WORKMATE WITH RPM SYSTEM?

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 WITH RPM SYSTEM?

The FDA product code for EP-WORKMATE WITH RPM SYSTEM 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-WORKMATEK063113EP-WORKMATEK041442EP-4 CLINICAL STIMUTATOR

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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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