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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K053453
Device Name HOMMED CENTRAL STATION, VERSION 3.5
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 Number870.1130
Classification Product Code
DXN  
Date Received12/12/2005
Decision Date 05/05/2006
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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