LungVision Tool

Bronchoscope (flexible Or Rigid)

Body Vision Medical Ltd.

The following data is part of a premarket notification filed by Body Vision Medical Ltd. with the FDA for Lungvision Tool.

Pre-market Notification Details

Device IDK172955
510k NumberK172955
Device Name:LungVision Tool
ClassificationBronchoscope (flexible Or Rigid)
Applicant Body Vision Medical Ltd. 34 SOKOLOV ST. Ramat Hasharon,  IL
ContactDorian Averbuch
CorrespondentPaul Dryden
ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-26
Decision Date2018-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290017652023 K172955 000
07290017652153 K172955 000
07290017652160 K172955 000
07290017652177 K172955 000
07290017652184 K172955 000
07290017652191 K172955 000
07290017652115 K172955 000
07290017652122 K172955 000
07290017652139 K172955 000
07290017652146 K172955 000
07290017652092 K172955 000
07290017652061 K172955 000
07290017652078 K172955 000
07290017652047 K172955 000
07290017652016 K172955 000
07290017652108 K172955 000

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