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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, monitoring (w/wo alarm)
510(k) Number K120087
Model 200
Device Name EXSPIRON
Original Applicant
411 waverly oaks road
building 1, suite 150
waltham,  MA  02452
Original Contact chas burr
Regulation Number868.1850
Classification Product Code
Subsequent Product Code
Date Received01/11/2012
Decision Date 09/26/2012
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