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 IDK193534
510k NumberK193534
Device Name:Monarch Platform
ClassificationBronchoscope (flexible Or Rigid)
Applicant Auris Health, Inc. 150 Shoreline Drive Redwood City,  CA  94065
ContactAnna Libman
CorrespondentAnna Libman
Auris Health, Inc. 150 Shoreline Drive Redwood City,  CA  94065
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B623MBR000211A0 K193534 000
B634MBR000211A1 K193534 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.