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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 K192595
Device Name ExSpiron 2Xi
Applicant
Respiratory Motion
80 Coolidge Hill Rd.
Watertown,  MA  02472
Applicant Contact Susan K. Hamann
Correspondent
Respiratory Motion
80 Coolidge Hill Rd.
Watertown,  MA  02472
Correspondent Contact Susan K. Hamann
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
BZQ  
Date Received09/20/2019
Decision Date 12/17/2019
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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