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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K120635
Device Name EASYONE PRO RESPIRATORY TESTING DEVICE
Original Applicant
NDD MEDIZITECHNIK AG
two dundee park
andover,  MA  01810
Original Contact gerard masiello
Regulation Number868.1890
Classification Product Code
BTY  
Date Received03/01/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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