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510(k) K210112

XChange Device, XChange System by Pneuma Therapeutics, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2023
Date Received
January 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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