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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 K061087
Device Name GENESIS OTC MONITOR
Applicant
Honeywell Hommed, LLC
2018 N. Durham Dr.
Houston,  TX  77008
Applicant Contact TOMMIE J MORGAN
Correspondent
Honeywell Hommed, LLC
2018 N. Durham Dr.
Houston,  TX  77008
Correspondent Contact TOMMIE J MORGAN
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/18/2006
Decision Date 06/09/2006
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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