HFM · Class II · 21 CFR 884.2720

FDA Product Code HFM: Monitor, Uterine Contraction, External (for Use In Clinic)

Leading manufacturers include Ventrex, Inc., Aequitron Medical, Inc. and Clinical Innovations, LLC.

23
Total
23
Cleared
155d
Avg days
1984
Since

FDA 510(k) Cleared Monitor, Uterine Contraction, External (for Use In Clinic) Devices (Product Code HFM)

23 devices
1–23 of 23
Cleared May 29, 2014
KOALA TOCO
K140163
Clinical Innovations, LLC
Obstetrics & Gynecology · 127d
Cleared Jul 12, 2006
FEATHERLITE AQUA TOCODYNAMOMETER
K061044
Ventrex, Inc.
Obstetrics & Gynecology · 89d
Cleared Jan 17, 2002
TOCO LITE, MODEL TD-01
K013477
Ventrex, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 22, 2000
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
Cleared Jan 18, 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811
Epic Medical Equipment Services, Inc.
Radiology · 151d
Cleared May 22, 1996
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K954847
Ocg Systems, Inc.
Obstetrics & Gynecology · 212d
Cleared May 26, 1993
BUBBLE TOCO
K920152
Utah Medical Products, Inc.
Obstetrics & Gynecology · 499d
Cleared Mar 29, 1991
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
K910282
Graphic Controls Corp.
Obstetrics & Gynecology · 65d
Cleared Jan 22, 1990
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030
Healthdyne, Inc.
Obstetrics & Gynecology · 230d
Cleared Mar 01, 1989
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K882080
Aequitron Medical, Inc.
Obstetrics & Gynecology · 288d
Cleared Mar 12, 1986
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
K853856
Aequitron Medical, Inc.
Obstetrics & Gynecology · 177d
Cleared Jun 19, 1984
TOCO DATA TELEPHONE TRANSMITTER DT100P
K840747
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 117d

About Product Code HFM - Regulatory Context