FDA 510(k) Applications for Medical Device Product Code "HFM"
(Monitor, Uterine Contraction, External (For Use In Clinic))

FDA 510(k) Number Applicant Device Name Decision Date
K040392 AMERICAN I.V. PRODUCTS, INC. TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING 09/14/2004
K140163 CLINICAL INNOVATIONS, LLC KOALA TOCO 05/29/2014
K992811 EPIC MEDICAL EQUIPMENT SERVICES, INC. TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING 01/18/2000
K954847 OCG SYSTEMS, INC. DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES 05/22/1996
K994353 PRECISION DYNAMICS CORP. SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 03/22/2000
K061044 VENTREX, INC. FEATHERLITE AQUA TOCODYNAMOMETER 07/12/2006
K013477 VENTREX, INC. TOCO LITE, MODEL TD-01 01/17/2002


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