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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K222340
Device Name Chartis Precision Catheter
Applicant
Pulmonx Corporation
700 Chesapeake Road
Redwood City,  CA  94063
Applicant Contact Aniket Khakhadiya
Correspondent
Pulmonx Corporation
700 Chesapeake Road
Redwood City,  CA  94063
Correspondent Contact Aniket Khakhadiya
Regulation Number868.5740
Classification Product Code
CBI  
Date Received08/03/2022
Decision Date 12/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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