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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K172196
Device Name ECOM™ Cardiac Output Monitoring System
Applicant
Ecom Medical, Inc.
27127 Calle Arroyo Suite 1905
San Juan Capistrano,  CA  92675
Applicant Contact Guy Lowery
Correspondent
Cheryl Blake
27392 Capricho
Mission Viejo,  CA  92692
Correspondent Contact Cheryl Blake
Regulation Number870.2770
Classification Product Code
DSB  
Subsequent Product Code
CBI  
Date Received07/21/2017
Decision Date 09/19/2017
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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