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FDA 510(k)

REMOTEIMAGE SYSTEM

K-Number: K994228 · 2000-02-22

ApplicantEtrauma.Com Corp.
Decision Date2000-02-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REMOTEIMAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etrauma.Com Corp.. It received FDA 510(k) clearance on 2000-02-22 under 510(k) number K994228. 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 REMOTEIMAGE SYSTEM?

REMOTEIMAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-22. The listed applicant is Etrauma.Com Corp.. The 510(k) number is K994228.

When did REMOTEIMAGE SYSTEM receive FDA 510(k) clearance?

REMOTEIMAGE SYSTEM received FDA 510(k) clearance on 2000-02-22, under 510(k) number K994228.

Who is the listed applicant for REMOTEIMAGE SYSTEM?

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

What is the FDA product code for REMOTEIMAGE SYSTEM?

The FDA product code for REMOTEIMAGE SYSTEM is LLZ.

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 Etrauma.Com Corp. 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.

K033825ORTHOPACS

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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