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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K163249
Device Name GoSpiro
Applicant
MONITORED THERAPEUTICS, INC.
5940 VENTURE DR., SUITE C
DUBLIN,  OH  43017
Applicant Contact William Zimlich
Correspondent
PROMEDIC, LLC
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/18/2016
Decision Date 03/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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