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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 K162131
FOIA Releasable 510(k) K162131
Device Name ExSpiron 1Xi
Applicant
Respiratory Motion Inc.
411 Waverly Oaks Road, Building 1, Suite 150
Waltham,  MA  02452
Applicant Contact Edwin Rule
Correspondent
Respiratory Motion Inc.
411 Waverly Oaks Road, Building 1, Suite 150
Waltham,  MA  02452
Correspondent Contact Edwin Rule
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
BZQ  
Date Received08/01/2016
Decision Date 05/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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