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FDA 510(k)

LungQ 4

K-Number: K250766 · 2025-10-02

ApplicantThirona BV
Decision Date2025-10-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LungQ 4 is a medical device manufactured by Thirona BV. It received FDA 510(k) clearance on 2025-10-02 under approval number K250766. 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 4?

LungQ 4 is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Thirona BV. The 510(k) number is K250766.

When was LungQ 4 approved by the FDA?

LungQ 4 received FDA 510(k) clearance on 2025-10-02, under approval number K250766.

What company makes LungQ 4?

LungQ 4 is manufactured by Thirona BV.

What is the FDA product code for LungQ 4?

The FDA product code for LungQ 4 is JAK.

Other Devices by Thirona BV

K232412LungQ v3.0.0

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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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