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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, uterine contraction, external (for use in clinic)
510(k) Number K040392
Device Name TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
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 Number884.2720
Classification Product Code
HFM  
Subsequent Product Code
HGL  
Date Received02/17/2004
Decision Date 09/14/2004
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
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