Monarch Bronchoscope

Reprocessed Bronchoscope

Auris Health Inc., A Johnson And Johnson Family Company

The following data is part of a premarket notification filed by Auris Health Inc., A Johnson And Johnson Family Company with the FDA for Monarch Bronchoscope.

Pre-market Notification Details

Device IDK203614
510k NumberK203614
Device Name:Monarch Bronchoscope
ClassificationReprocessed Bronchoscope
Applicant Auris Health Inc., A Johnson And Johnson Family Company 150 Shoreline Drive Redwood City,  CA  94065
ContactSomi Ekwealor
CorrespondentSomi Ekwealor
Auris Health Inc., A Johnson And Johnson Family Company 150 Shoreline Drive Redwood City,  CA  94065
Product CodeQNW  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-03-11

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