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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 a medical device manufactured by Thirona BV. It received FDA 510(k) clearance on 2024-01-08 under approval 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. It is manufactured by Thirona BV. The 510(k) number is K232412.

When was LungQ v3.0.0 approved by the FDA?

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

What company makes LungQ v3.0.0?

LungQ v3.0.0 is manufactured by Thirona BV.

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

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

Other Devices by Thirona BV

K250766LungQ 4

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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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