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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 K033488
Device Name CMI MAGNETOCARDIOGRAPH
Applicant
Cmi Cardiomag Imaging, Inc.
450 Duane Ave.
Schenectady,  NY  12304
Applicant Contact STEVEN KARR
Correspondent
Cmi Cardiomag Imaging, Inc.
450 Duane Ave.
Schenectady,  NY  12304
Correspondent Contact STEVEN KARR
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/04/2003
Decision Date 07/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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