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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 K090367
Device Name SE-601 SERIES ELECTROCARDIOGRAPH
Applicant
Edan Instruments, Inc.
1 Odell Plz.
Yonkers,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
Edan Instruments, Inc.
1 Odell Plz.
Yonkers,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/13/2009
Decision Date 06/03/2009
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
Recalls CDRH Recalls
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