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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K142693
Device Name ZywieAI Software Library
Applicant
Zywie, Inc.
12000 Findley Road, Suite 360
Johns Creek,  GA  30097
Applicant Contact Latha Ganeshan
Correspondent
AJW TECHNOLOGY CONSULTANTS, INC.
445 APOLLO BEACH BLVD.
APOLLO BEACH,  FL  33572
Correspondent Contact Jon Ward
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/22/2014
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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