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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 K083199
Device Name CHARTIS CONSOLE
Applicant
PULMONX, INC.
1047 ELWELL COURT
PALO ALTO,  CA  94303
Applicant Contact SUZON LOMMEL
Correspondent
PULMONX, INC.
1047 ELWELL COURT
PALO ALTO,  CA  94303
Correspondent Contact SUZON LOMMEL
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/30/2008
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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