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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 K043380
Device Name MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Applicant
MONEBO TECHNOLOGIES, INC.
1800 BARTON CREEK BLVD
AUSTIN,  TX  78735
Applicant Contact DALE J MISCZYNSKI
Correspondent
MONEBO TECHNOLOGIES, INC.
1800 BARTON CREEK BLVD
AUSTIN,  TX  78735
Correspondent Contact DALE J MISCZYNSKI
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/08/2004
Decision Date 04/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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