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FDA 510(k)

INFRA VISION IMAGING SYSTEM

K-Number: K945297 · 1994-12-20

ApplicantGabriel Medical, Inc.
Decision Date1994-12-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INFRA VISION IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gabriel Medical, Inc.. It received FDA 510(k) clearance on 1994-12-20 under 510(k) number K945297. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFRA VISION IMAGING SYSTEM?

INFRA VISION IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-20. The listed applicant is Gabriel Medical, Inc.. The 510(k) number is K945297.

When did INFRA VISION IMAGING SYSTEM receive FDA 510(k) clearance?

INFRA VISION IMAGING SYSTEM received FDA 510(k) clearance on 1994-12-20, under 510(k) number K945297.

Who is the listed applicant for INFRA VISION IMAGING SYSTEM?

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

What is the FDA product code for INFRA VISION IMAGING SYSTEM?

The FDA product code for INFRA VISION IMAGING SYSTEM is GCJ.

Related Clinical Trials

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Other records listing Gabriel Medical, Inc. 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.

K960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITK945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIK940019GABRIEL URETERAL ILLUMINATOR SYSTEMK901385GABRIEL MEDICAL CLS THERMAL RECORDER

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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