GlideScope BFlex 2.8 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 2.8 Single-use Bronchoscope.

Pre-market Notification Details

Device IDK211947
510k NumberK211947
Device Name:GlideScope BFlex 2.8 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-23
Decision Date2021-11-03

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