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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K043361
Device Name ACCUHEART ELECTRODE BELT
Applicant
Advanced Bioelectric Corporation
2160 Johnson St.
Montreal, Qc,  CA H4M 1M1
Applicant Contact MARC-ANDRE COTE
Correspondent
Advanced Bioelectric Corporation
2160 Johnson St.
Montreal, Qc,  CA H4M 1M1
Correspondent Contact MARC-ANDRE COTE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/07/2004
Decision Date 03/22/2005
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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