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510(k) K203614

Device
Monarch Bronchoscope
Applicant
Auris Health Inc., A Johnson And Johnson Family Company
510(k) number
K203614
Product code
QNW  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-11
Date received
2020-12-10
Regulation
874.4680
Classification name
Reprocessed Bronchoscope
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Somi Ekwealor
Address
150 Shoreline Dr. Redwood CA US 94065 94065

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company2023-11-28

Legacy Summary#

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FDA Review#

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