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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K112858
Device Name GENESIS TOUCH SYSTEM
Applicant
Honeywell Hommed, LLC
3400 Intertech Dr.
Suite 200
Brookfield,  WI  53045
Applicant Contact CLAUDIA JACKSON
Correspondent
Honeywell Hommed, LLC
3400 Intertech Dr.
Suite 200
Brookfield,  WI  53045
Correspondent Contact CLAUDIA JACKSON
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/30/2011
Decision Date 01/24/2012
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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