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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
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