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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 K090249
Device Name MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
Applicant
HARBINGER MEDICAL, INC.
10125 CROSSTOWN CIRCLE
SUITE 105
EDEN PRAIRIE,  MN  55344 -3316
Applicant Contact HAROLD HOIUM
Correspondent
HARBINGER MEDICAL, INC.
10125 CROSSTOWN CIRCLE
SUITE 105
EDEN PRAIRIE,  MN  55344 -3316
Correspondent Contact HAROLD HOIUM
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/02/2009
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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