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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 K061822
Device Name OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
Applicant
Omron Healthcare, Inc.
3460 Pointe Creek Court #102
Bonita Springs,  FL  34134
Applicant Contact DONNA DJINOVICH
Correspondent
Omron Healthcare, Inc.
3460 Pointe Creek Court #102
Bonita Springs,  FL  34134
Correspondent Contact DONNA DJINOVICH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/28/2006
Decision Date 08/02/2006
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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