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FDA 510(k)

EPS

K-Number: K974504 · 1998-02-27

ApplicantE For M Imaging Systems Div., Marquette Electronic
Decision Date1998-02-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EPS is the device name listed in this FDA 510(k) record. The listed applicant is E For M Imaging Systems Div., Marquette Electronic. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K974504. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPS?

EPS is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is E For M Imaging Systems Div., Marquette Electronic. The 510(k) number is K974504.

When did EPS receive FDA 510(k) clearance?

EPS received FDA 510(k) clearance on 1998-02-27, under 510(k) number K974504.

Who is the listed applicant for EPS?

The FDA 510(k) record lists E For M Imaging Systems Div., Marquette Electronic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPS?

The FDA product code for EPS is LLZ.

Related PubMed Literature

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.

PMID: 35761948Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers.Medical devices (Auckland, N.Z.) ()PMID: 35047938Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy.Frontiers in medical technology ()PMID: 36691763An economic evaluation of vagus nerve stimulation as an adjunctive treatment to anti-seizure medications for the treatment of drug resistant epilepsy in the United States.Journal of medical economics ()

Other records listing E For M Imaging Systems Div., Marquette Electronic 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.

K955184ACCULUPE

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, 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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