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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K060766
Device Name PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
Applicant
Omron Healthcare, Inc.
3460 Pointe Creek Court #102
Bonita Springs,  FL  34134
Applicant Contact DONNA DJINOVICH
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact SILVIA ANKOVA
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/22/2006
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 Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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