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FDA 510(k)

XChange Device, XChange System

K-Number: K210112 · 2023-01-30

ApplicantPneuma Therapeutics, Inc.
Decision Date2023-01-30
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

XChange Device, XChange System is a medical device manufactured by Pneuma Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-30 under approval number K210112. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XChange Device, XChange System?

XChange Device, XChange System is a medical device that received FDA 510(k) clearance on 2023-01-30. It is manufactured by Pneuma Therapeutics, Inc.. The 510(k) number is K210112.

When was XChange Device, XChange System approved by the FDA?

XChange Device, XChange System received FDA 510(k) clearance on 2023-01-30, under approval number K210112.

What company makes XChange Device, XChange System?

XChange Device, XChange System is manufactured by Pneuma Therapeutics, Inc..

What is the FDA product code for XChange Device, XChange System?

The FDA product code for XChange Device, XChange System is CCK.

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Related PubMed Literature

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Official Source

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