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510(k) K180011

Pulmonx Chartis Tablet Console by Pulmonx Corporation — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2018
Date Received
January 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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