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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 K100928
Device Name MICRO DIARY SPIROMETER
Applicant
VIASYS RESPIRATORY CARE INC.
22745 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact MERRITT GIRGIS
Correspondent
VIASYS RESPIRATORY CARE INC.
22745 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact MERRITT GIRGIS
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/05/2010
Decision Date 03/07/2011
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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