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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 K173181
Device Name ExSpiron 1Xi
Applicant
Respiratory Motion, Inc.
411 Waverly Oaks Rd., Bldg. 1, Suite 150
Waltham,  MA  02452
Applicant Contact Susan Hamann
Correspondent
Respiratory Motion, Inc.
411 Waverly Oaks Rd., Bldg. 1, Suite 150
Waltham,  MA  02452
Correspondent Contact Susan Hamann
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
BZQ  
Date Received09/29/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02336022
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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