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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K193043
Device Name Critical Alert CommonPath Enterprise
Applicant
Critical Alert
4901 Belfort Rd., Suite 130
Jacksonville,  FL  32256
Applicant Contact John Elms
Correspondent
Speed TO Market, Inc.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Code
PHC  
Date Received10/31/2019
Decision Date 05/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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