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FDA 510(k)

LungQ v3.0.0

K-Number: K232412 · 2024-01-08

ApplicantThirona BV
Decision Date2024-01-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LungQ v3.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Thirona BV. It received FDA 510(k) clearance on 2024-01-08 under 510(k) number K232412. 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 v3.0.0?

LungQ v3.0.0 is a medical device that received FDA 510(k) clearance on 2024-01-08. The listed applicant is Thirona BV. The 510(k) number is K232412.

When did LungQ v3.0.0 receive FDA 510(k) clearance?

LungQ v3.0.0 received FDA 510(k) clearance on 2024-01-08, under 510(k) number K232412.

Who is the listed applicant for LungQ v3.0.0?

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

What is the FDA product code for LungQ v3.0.0?

The FDA product code for LungQ v3.0.0 is JAK.

Other records listing Thirona BV 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.

K250766LungQ 4

Related Devices (Code: JAK)

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.

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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.

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