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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 K120880
Model Z-7000-0101
Device Name ORBIT
Original Applicant
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC
6901 e. fish lake road
suite 188
maple grove,  MN  55369
Original Contact mary kay jensen
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/23/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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