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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 K063044
Device Name CARDIOBELT ELECTRODE BELT
Applicant
Monebo Technologies, Inc.
1800 Barton Creek Blvd.
Austin,  TX  78735 -1606
Applicant Contact DALE J MISCZYNSKI
Correspondent
Monebo Technologies, Inc.
1800 Barton Creek Blvd.
Austin,  TX  78735 -1606
Correspondent Contact DALE J MISCZYNSKI
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/04/2006
Decision Date 03/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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