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FDA 510(k)

CARDIOPACS

K-Number: K120514 · 2012-07-05

ApplicantLumedx
Decision Date2012-07-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOPACS is the device name listed in this FDA 510(k) record. The listed applicant is Lumedx. It received FDA 510(k) clearance on 2012-07-05 under 510(k) number K120514. 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 CARDIOPACS?

CARDIOPACS is a medical device that received FDA 510(k) clearance on 2012-07-05. The listed applicant is Lumedx. The 510(k) number is K120514.

When did CARDIOPACS receive FDA 510(k) clearance?

CARDIOPACS received FDA 510(k) clearance on 2012-07-05, under 510(k) number K120514.

Who is the listed applicant for CARDIOPACS?

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

What is the FDA product code for CARDIOPACS?

The FDA product code for CARDIOPACS is LLZ.

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Other records listing Lumedx 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.

K123466HEALTHVIEW ECG MANAGER

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

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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