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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 K090034
Device Name EASY ON-PC SPIROMETER
Applicant
NDD MEDIZITECHNIK AG
TWO DUNDEE PARK
ANDOVER,  MA  01810
Applicant Contact JERRY MASIELLO
Correspondent
NDD MEDIZITECHNIK AG
TWO DUNDEE PARK
ANDOVER,  MA  01810
Correspondent Contact JERRY MASIELLO
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/06/2009
Decision Date 06/02/2009
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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