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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 K043018
Device Name OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
Applicant
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Applicant Contact LARRY LEPLEY
Correspondent
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Correspondent Contact LARRY LEPLEY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/02/2004
Decision Date 11/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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