Monarch Bronchoscope— 510(k) K203614

Substantially Equivalent

Auris Health, Inc., A Johnson and Johnson Family Company

FDA 510(k) clearance K203614 for Monarch Bronchoscope, Substantially Equivalent on 2021-03-11. Applicant: Auris Health, Inc., A Johnson and Johnson Family Company.

Clearance details

Applicant
Auris Health, Inc., A Johnson and Johnson Family Company
Product code
Code QNW
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redwood, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.