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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K040480
Device Name SONOTRAX ULTRASONIC POCKET DOPPLER
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 Number884.2660
Classification Product Code
KNG  
Date Received02/25/2004
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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