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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K001091
Device Name CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
Applicant
Next Millennium Software Solutions, Inc.
7224 W. 29th Way
Hialeah,  FL  33018
Applicant Contact JUAN OMAR PEREZ
Correspondent
Next Millennium Software Solutions, Inc.
7224 W. 29th Way
Hialeah,  FL  33018
Correspondent Contact JUAN OMAR PEREZ
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/04/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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