Monitor, Heart Rate, Fetal, Ultrasonic

Product Code: HEL

Obstetrics/Gynecology Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.2660


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HEL

3910Monitor, Heart Rate, Fetal, UltrasonicFetal Ultrasonic Monitor And Accessories.

Total Product Life Cycle (TPLC) Devices

3910Monitor, Heart Rate, Fetal, UltrasonicFetal Ultrasonic Monitor And Accessories.

Pre-market Notifications for HEL

K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMEDICAL CABLES, INC.
K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCARD GUARD SCIENTIFIC SURVIVAL, LTD.
K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.
K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006ALEXANDER MFG. CO.
K933816SONICAID MODEL P110 FETAL HEAR DETECTOROXFORD INSTRUMENTS, PLC.
K930714SONICAID MODEL TEAM FECG IUPOXFORD INSTRUMENTS, PLC.
K780035MINIVISORMETRIX TEKNIKA, INC.

Global Unique Device Identification Database

00840682142564MONITOR, HEART RATE, FETAL, ULTRASONIC
00840682104210MONITOR, HEART RATE, FETAL, ULTRASONIC
00840682104111MONITOR, HEART RATE, FETAL, ULTRASONIC

Maude Adverse Events

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.2019-11-12
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.2019-11-11
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.2019-10-29
GE COROMETRICS NAUTILUS 5700LAX ULTRASOUND TRANSDUCER WITH WINGCOROMETRICS MEDICAL SYSTEMS, INC.2019-10-28
GE COROMETRICS NAUTILUS 5700 HAX ULTRASOUND TRANSDUCER WITH KNOBCOROMETRICS MEDICAL SYSTEMS, INC.2019-10-28
GE COROMETRICS NAUTILUS 5700 HAX ULTRASOUND TRANSDUCER WITH KNOBCOROMETRICS MEDICAL SYSTEMS, INC.2019-10-22
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.2019-10-21
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.2019-10-21
GE COROMETRIC ELECTRONIC FETAL MONITORGE2018-03-22
GE COROMETRIC ELECTRONIC FETAL MONITORGE2018-03-22
GE FETAL MONITORGE HEALTHCARE2015-05-08
SONICAIDHUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS2013-04-11
SONICAIDHUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS2013-04-11
COROMETRICSCOROMETRICS2011-01-25
FETAL MONITORNICOLET VASCULAR2007-03-20
NAUTILUS TOCO TRANSDUCERGENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2002-06-26
PERITRONICSLIFE SERVE TECHNOLOGIES1999-06-16
FETALGARD 3000ANALOGIC CORPORATION1998-12-14
FETALGUARDAIR SHIELDS - VICKERS1998-11-16
FETAL GUARDAIR SHIELDS - VICKERS1998-11-16
CLINICOMP CIS AND FMRD SYSTEMCLINICOMP INTL.1998-06-04
UNKCARDIOTOCOGRAPH (CTG) MONITORING OF FETUS DURING LABOR*1998-04-20
*FETAL HEART MONITORCOROMETRIC1997-11-25
N/AN/AHEWLETT PACKARD1992-08-24
FETAL HEART MONITORHEWLETT PACKARD1992-08-04

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