FDA 510(k)

Monarch Bronchoscope

K-Number: K203614 · 2021-03-11

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

Decision Date2021-03-11

Product CodeQNW

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Monarch Bronchoscope is the device name listed in this FDA 510(k) record. The listed applicant is Auris Health, Inc., A Johnson and Johnson Family Company. It received FDA 510(k) clearance on 2021-03-11 under 510(k) 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. The listed applicant is Auris Health, Inc., A Johnson and Johnson Family Company. The 510(k) number is K203614.

When did Monarch Bronchoscope receive FDA 510(k) clearance?

Monarch Bronchoscope received FDA 510(k) clearance on 2021-03-11, under 510(k) number K203614.

Who is the listed applicant for Monarch Bronchoscope?

The FDA 510(k) record lists Auris Health, Inc., A Johnson and Johnson Family Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monarch Bronchoscope?

The FDA product code for Monarch Bronchoscope is QNW.

Other records listing Auris Health, Inc., A Johnson and Johnson Family Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231473Monarch Bronchoscope

Related Devices (Code: QNW)

K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.