Monarch Bronchoscope
K-Number: K203614 · 2021-03-11
Decision Date2021-03-11
Product CodeQNW
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Monarch Bronchoscope is a medical device manufactured by Auris Health, Inc., A Johnson and Johnson Family Company. It received FDA 510(k) clearance on 2021-03-11 under approval number K203614. The device is classified under product code QNW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Monarch Bronchoscope?
Monarch Bronchoscope is a medical device that received FDA 510(k) clearance on 2021-03-11. It is manufactured by Auris Health, Inc., A Johnson and Johnson Family Company. The 510(k) number is K203614.
When was Monarch Bronchoscope approved by the FDA?
Monarch Bronchoscope received FDA 510(k) clearance on 2021-03-11, under approval number K203614.
What company makes Monarch Bronchoscope?
Monarch Bronchoscope is manufactured by Auris Health, Inc., A Johnson and Johnson Family Company.
What is the FDA product code for Monarch Bronchoscope?
The FDA product code for Monarch Bronchoscope is QNW.
Other Devices by Auris Health, Inc., A Johnson and Johnson Family Company
Related Devices (Code: QNW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.