Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices

FDA submissions for Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices in the Obstetrics/Gynecology (OB) review panel, including product codes and regulations.

Section range: §§ 884.2050–884.2990

CFR Part: 884

Product Codes

Product CodeDevice NameRegulationClassDevices
HEOAnalyzer, Data, Obstetric884.205031
HEMImager, Ultrasonic Obstetric-Gynecologic884.2225230
HENCaliper, Fetal Head, Ultrasonic884.222520
HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic884.222521
HHXHolograph, Fetal, Acoustical884.222520
KXNMonitor, Cardiac, Fetal884.260022
HGOMonitor, Electroencephalographic, Fetal (And Accessories)884.262030
HFPMonitor, Phonocardiographic, Fetal884.264020
HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic884.266023
HEJMonitor, Hemic Sound, Ultrasonic884.266020
HEKMonitor, Heart Sound, Fetal, Ultrasonic884.266025
HELMonitor, Heart Rate, Fetal, Ultrasonic884.266027
HEPMonitor, Blood-Flow, Ultrasonic884.266024
HEQMonitor, Pressure, Arterial, Fetal, Ultrasonic884.266020
KNGMonitor, Ultrasonic, Fetal884.2660260
LXEDoppler, Fetal, Ultrasound884.266020
MAAMonitor, Fetal Doppler Ultrasound884.266029
HGPElectrode, Circular (Spiral), Scalp And Applicator884.2675217
HIQElectrode, Clip, Fetal Scalp (And Applicator)884.268530
HFNTransducer, Pressure, Intrauterine884.270029
HFORecorder, Pressure, Intrauterine884.270024
HGSCatheter, Intrauterine And Introducer884.270022
KXOMonitor, Pressure, Intrauterine884.2700226
HFMMonitor, Uterine Contraction, External (For Use In Clinic)884.2720224
OSPUterine Electromyographic Monitor884.2720210
LQKHome Uterine Activity Monitor884.273027
MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)884.273020
HGMSystem, Monitoring, Perinatal884.27402214
HGNStethoscope, Fetal884.290012
HGLTransducer, Ultrasonic, Obstetric884.2960236
IYMSystem, Telethermographic, Infrared884.298038
LHPSystem, Telethermographic (Sole Diagnostic Screen)884.298030
LHQSystem, Telethermographic (Adjunctive Use)884.2980140
KXZSystem, Thermographic, Liquid Crystal, Powered (Adjunctive Use)884.298237
KYASystem, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)884.298215
LHMSystem, Thermographic, Liquid Crystal884.298211
LHRSystem, Thermographic, Liquid Crystal (Sole Diagnostic Screen)884.298230
NHMSheet, Recording, Breast Examination884.299022
NKASystem, Documentation, Breast Lesion884.299024
Innolitics

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