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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 K001671
Device Name ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
Applicant
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Applicant Contact OSAMU SHIRASAKI
Correspondent
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact OSAMU SHIRASAKI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/01/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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