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FDA 510(k)

VS3

K-Number: K123467 · 2013-04-17

ApplicantVisionsense, Ltd.
Decision Date2013-04-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VS3 is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2013-04-17 under 510(k) number K123467. 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 VS3?

VS3 is a medical device that received FDA 510(k) clearance on 2013-04-17. The listed applicant is Visionsense, Ltd.. The 510(k) number is K123467.

When did VS3 receive FDA 510(k) clearance?

VS3 received FDA 510(k) clearance on 2013-04-17, under 510(k) number K123467.

Who is the listed applicant for VS3?

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

What is the FDA product code for VS3?

The FDA product code for VS3 is GCJ.

Other records listing Visionsense, 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.

K223020VS3-Iridium System (VS3-IR)K210265VS3 Iridium SytemK171208Trans-anal IntroducerK153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMK131434VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMK082355VISIONSENSE STEREOSCOPIC VISION SYSTEM

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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

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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