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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K180011
Device Name Pulmonx Chartis Tablet Console
Applicant
Pulmonx Corporation
700 Chesapeake Dr.
Redwood Citry,  CA  94063
Applicant Contact Sherry Kim
Correspondent
Pulmonx Corporation
700 Chesapeake Dr.
Redwood Citry,  CA  94063
Correspondent Contact Sherry Kim
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/02/2018
Decision Date 07/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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