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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
FOIA Releasable 510(k) K120087
Device Name EXSPIRON
Applicant
Respiratory Motion, Inc.
411 Waverly Oaks Rd., Bldg. 1, Suite 150
Waltham,  MA  02452
Applicant Contact CHAS BURR
Correspondent
Respiratory Motion, Inc.
411 Waverly Oaks Rd., Bldg. 1, Suite 150
Waltham,  MA  02452
Correspondent Contact CHAS BURR
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
BZQ  
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
Predetermined Change
Control Plan Authorized		 No
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