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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K040819
Device Name TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
Applicant
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER,  MD  21076
Applicant Contact GREGORY FALK
Correspondent
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER,  MD  21076
Correspondent Contact GREGORY FALK
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/30/2004
Decision Date 08/16/2004
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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