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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 K061780
Device Name TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
Applicant
Rozinn Electronics, Inc.
71-22 Myrtle Ave.
Glendale,  NY  11385
Applicant Contact MARK ROSOFF
Correspondent
Rozinn Electronics, Inc.
71-22 Myrtle Ave.
Glendale,  NY  11385
Correspondent Contact MARK ROSOFF
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/26/2006
Decision Date 09/15/2006
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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