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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K210112
Device Name XChange Device, XChange System
Pneuma Therapeutics, Inc.
4090 E Bujia Primera
Tucson,  AZ  85718 -6164
Applicant Contact William Densel
Regulatory and Quality Solutions LLC
2790 Mosside Blvd #800
Monroeville,  PA  15146
Correspondent Contact Michele McDonald
Regulation Number868.1400
Classification Product Code
Subsequent Product Code
Date Received01/19/2021
Decision Date 01/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No