HFM · Class II · 21 CFR 884.2720

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

Leading manufacturers include Aequitron Medical, Inc., Healthdyne, Inc. and Graphic Controls Corp..

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 Mar 22, 2000
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
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

About Product Code HFM - Regulatory Context