Monarch Bronchoscope
K-Number: K231473 · 2023-11-28
Decision Date2023-11-28
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 2023-11-28 under approval number K231473. 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 2023-11-28. It is manufactured by Auris Health, Inc., A Johnson and Johnson Family Company. The 510(k) number is K231473.
When was Monarch Bronchoscope approved by the FDA?
Monarch Bronchoscope received FDA 510(k) clearance on 2023-11-28, under approval number K231473.
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.