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FDA 510(k)

ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY

K-Number: K935186 · 1995-01-03

ApplicantElectrophysiology Systems, Inc.
Decision Date1995-01-03
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY is the device name listed in this FDA 510(k) record. The listed applicant is Electrophysiology Systems, Inc.. It received FDA 510(k) clearance on 1995-01-03 under 510(k) number K935186. 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 ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY?

ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY is a medical device that received FDA 510(k) clearance on 1995-01-03. The listed applicant is Electrophysiology Systems, Inc.. The 510(k) number is K935186.

When did ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY receive FDA 510(k) clearance?

ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY received FDA 510(k) clearance on 1995-01-03, under 510(k) number K935186.

Who is the listed applicant for ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY?

The FDA 510(k) record lists Electrophysiology Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY?

The FDA product code for ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY 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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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

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

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