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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 K130170
Device Name EXSPIRON 1XI
Applicant
Respiratory Motion, Inc.
411 Waverly Oaks Rd., Bldg. 1, Suite 150
Waltham,  MA  02452
Applicant Contact JENNY FREEMAN, MD
Correspondent
Respiratory Motion, Inc.
411 Waverly Oaks Rd., Bldg. 1, Suite 150
Waltham,  MA  02452
Correspondent Contact JENNY FREEMAN, MD
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
BZQ  
Date Received01/24/2013
Decision Date 05/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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