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FDA 510(k)

XV Lung Ventilation Analysis Software

K-Number: K193293 · 2020-05-14

Applicant4Dx Limited
Decision Date2020-05-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XV Lung Ventilation Analysis Software is a medical device manufactured by 4Dx Limited. It received FDA 510(k) clearance on 2020-05-14 under approval number K193293. 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 XV Lung Ventilation Analysis Software?

XV Lung Ventilation Analysis Software is a medical device that received FDA 510(k) clearance on 2020-05-14. It is manufactured by 4Dx Limited. The 510(k) number is K193293.

When was XV Lung Ventilation Analysis Software approved by the FDA?

XV Lung Ventilation Analysis Software received FDA 510(k) clearance on 2020-05-14, under approval number K193293.

What company makes XV Lung Ventilation Analysis Software?

XV Lung Ventilation Analysis Software is manufactured by 4Dx Limited.

What is the FDA product code for XV Lung Ventilation Analysis Software?

The FDA product code for XV Lung Ventilation Analysis Software is JAK.

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Related PubMed Literature

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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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