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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
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 (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No