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FDA 510(k)

LungVision Tool

K-Number: K172955 · 2018-04-26

ApplicantBodyvision Medical , Ltd.
Decision Date2018-04-26
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LungVision Tool is the device name listed in this FDA 510(k) record. The listed applicant is Bodyvision Medical , Ltd.. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K172955. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungVision Tool?

LungVision Tool is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Bodyvision Medical , Ltd.. The 510(k) number is K172955.

When did LungVision Tool receive FDA 510(k) clearance?

LungVision Tool received FDA 510(k) clearance on 2018-04-26, under 510(k) number K172955.

Who is the listed applicant for LungVision Tool?

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

What is the FDA product code for LungVision Tool?

The FDA product code for LungVision Tool is EOQ.

Other records listing Bodyvision Medical , 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.

K240943LungVisionK183593Lung Vision SystemK163622Lung Vision

Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

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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