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FDA 510(k)

ARC

K-Number: K934669 · 1994-04-26

ApplicantMedelec , Ltd.
Decision Date1994-04-26
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARC is the device name listed in this FDA 510(k) record. The listed applicant is Medelec , Ltd.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K934669. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARC?

ARC is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Medelec , Ltd.. The 510(k) number is K934669.

When did ARC receive FDA 510(k) clearance?

ARC received FDA 510(k) clearance on 1994-04-26, under 510(k) number K934669.

Who is the listed applicant for ARC?

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

What is the FDA product code for ARC?

The FDA product code for ARC is BSZ.

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: 41476571Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report.Journal of pathology informatics ()PMID: 40948288[Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States].Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation ()PMID: 40400654Prescription Digital Therapeutics Research Across Clinical, Engagement, Regulatory, and Implementation Domains: A Bibliometric and Thematic Study.Cureus ()PMID: 39150225Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases.Journal of comparative effectiveness research ()

Other records listing Medelec , Ltd. 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.

K965065TECA. MILLENNIUMK964280DG NERVUSK954157DG PORTABLE SYSTEMK953799DG EXAMINER PLUSK953732TECA PREMIEREK934670DG 3P SYSTEM

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Related Devices (Code: BSZ)

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.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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