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FDA 510(k)

LungQ Software

K-Number: K173821 · 2018-06-05

ApplicantThirona Corporation
Decision Date2018-06-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LungQ Software is the device name listed in this FDA 510(k) record. The listed applicant is Thirona Corporation. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K173821. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungQ Software?

LungQ Software is a medical device that received FDA 510(k) clearance on 2018-06-05. The listed applicant is Thirona Corporation. The 510(k) number is K173821.

When did LungQ Software receive FDA 510(k) clearance?

LungQ Software received FDA 510(k) clearance on 2018-06-05, under 510(k) number K173821.

Who is the listed applicant for LungQ Software?

The FDA 510(k) record lists Thirona Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LungQ Software?

The FDA product code for LungQ Software is JAK.

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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.

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