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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K083821
Device Name VITAL SIGNS MONITOR
Applicant
EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received12/22/2008
Decision Date 05/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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