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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 K173830
Device Name MAC VU360 Resting ECG Analysis System
Applicant
GE Medical Systems Information Technologies, Inc.
9900 West Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Marcella Entwisle
Correspondent
GE Medical Systems Information Technologies, Inc.
9900 West Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Marcella Entwisle
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQK   DXH  
Date Received12/18/2017
Decision Date 09/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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