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FDA 510(k)

NIO 5MP-21 AND MDNG-5121 CB

K-Number: K062621 · 2007-03-19

ApplicantBarcoview
Decision Date2007-03-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NIO 5MP-21 AND MDNG-5121 CB is the device name listed in this FDA 510(k) record. The listed applicant is Barcoview. It received FDA 510(k) clearance on 2007-03-19 under 510(k) number K062621. 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 NIO 5MP-21 AND MDNG-5121 CB?

NIO 5MP-21 AND MDNG-5121 CB is a medical device that received FDA 510(k) clearance on 2007-03-19. The listed applicant is Barcoview. The 510(k) number is K062621.

When did NIO 5MP-21 AND MDNG-5121 CB receive FDA 510(k) clearance?

NIO 5MP-21 AND MDNG-5121 CB received FDA 510(k) clearance on 2007-03-19, under 510(k) number K062621.

Who is the listed applicant for NIO 5MP-21 AND MDNG-5121 CB?

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

What is the FDA product code for NIO 5MP-21 AND MDNG-5121 CB?

The FDA product code for NIO 5MP-21 AND MDNG-5121 CB is LLZ.

Other records listing Barcoview 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.

K062905NIO FUSION 4MP; MDNC 4130K062131NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BBK061924CORONIS 3MP AND MDCG 3120-CBK061928CORONIS COLOR 2MP AND MDCC 2121K061927CORONIS COLOR 3MP AND MDCC 3120-DLK061926CORONIS 2MP AND MDCG 2121 - CB

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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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