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HFM — Monitor, Uterine Contraction, External (For Use In Clinic) Class II

FDA Device Classification

Classification Details

Product Code
HFM
Device Class
Class II
Regulation Number
884.2720
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140163clinical innovationsKOALA TOCOMay 29, 2014
K061044ventrexFEATHERLITE AQUA TOCODYNAMOMETERJuly 12, 2006
K040392american i.v. productsTRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGSeptember 14, 2004
K013477ventrexTOCO LITE, MODEL TD-01January 17, 2002
K994353precision dynamicsSECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565March 22, 2000
K992811epic medical equipment servicesTRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGJanuary 18, 2000
K954847ocg systemsDISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESMay 22, 1996
K952579scientific device manufacturerTOCO TRANSDUCERAugust 4, 1995
K920152utah medical productsBUBBLE TOCOMay 26, 1993
K910282graphic controlsMEDI-TRACE(R) DISPOSABLE TOCOTONOMETERMarch 29, 1991
K904691air-shields vickersAIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTFebruary 19, 1991
K903623corometrics medical systemsMODEL600 UTERINE ACTIVITY MONITORNovember 7, 1990
K902104orion industriesORION WATCHGUARDOctober 25, 1990
K894030healthdyneMODEL 37 UTERINE CONTRACTION ACTIVITY MONITORJanuary 22, 1990
K893770tokos medicalTERM GUARD II DEVICENovember 3, 1989
K891997corometrics medical systemsCATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCERJune 8, 1989
K882080aequitron medicalMODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.March 1, 1989
K873150pediatric diagnostic servicePDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.March 11, 1988
K874631carelinkHEALTHPHONE TOCO MODELMarch 11, 1988
K860933international biomedicsAIR-CUSHION TOCOTONOMETERJuly 9, 1986