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FDA 510(k)

VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)

K-Number: K082667 · 2008-10-30

ApplicantVisionsense, Ltd.
Decision Date2008-10-30
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2008-10-30 under 510(k) number K082667. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)?

VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) is a medical device that received FDA 510(k) clearance on 2008-10-30. The listed applicant is Visionsense, Ltd.. The 510(k) number is K082667.

When did VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) receive FDA 510(k) clearance?

VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) received FDA 510(k) clearance on 2008-10-30, under 510(k) number K082667.

Who is the listed applicant for VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)?

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 VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)?

The FDA product code for VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) is EOB.

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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 SYSTEMK123467VS3

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Related Devices (Code: EOB)

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K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, 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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