Monarch Platform

Bronchoscope (flexible Or Rigid)

Auris Health, Inc.

The following data is part of a premarket notification filed by Auris Health, Inc. with the FDA for Monarch Platform.

Pre-market Notification Details

Device IDK211493
510k NumberK211493
Device Name:Monarch Platform
ClassificationBronchoscope (flexible Or Rigid)
Applicant Auris Health, Inc. 150 Shoreline Drive Redwood,  CA  94065
ContactShikha Gola
CorrespondentShikha Gola
Auris Health, Inc. 150 Shoreline Drive Redwood,  CA  94065
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-13
Decision Date2021-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B634MON0007091 K211493 000

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