GlideScope BFlex 3.8 Single-Use Bronchoscope

Bronchoscope (flexible Or Rigid)

Verathon Medical (Canada) ULC

The following data is part of a premarket notification filed by Verathon Medical (canada) Ulc with the FDA for Glidescope Bflex 3.8 Single-use Bronchoscope.

Pre-market Notification Details

Device IDK193488
510k NumberK193488
Device Name:GlideScope BFlex 3.8 Single-Use Bronchoscope
ClassificationBronchoscope (flexible Or Rigid)
Applicant Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby,  CA V5c 5a9
ContactTeresa Davidson
CorrespondentTeresa Davidson
Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby,  CA V5c 5a9
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
510k Review PanelEar Nose & Throat
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-01-16

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