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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 the device name listed in this FDA 510(k) record. The listed applicant is Pneuma Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) 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. The listed applicant is Pneuma Therapeutics, Inc.. The 510(k) number is K210112.

When did XChange Device, XChange System receive FDA 510(k) clearance?

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

Who is the listed applicant for XChange Device, XChange System?

The FDA 510(k) record lists Pneuma Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: CCK)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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