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Uterine Electromyographic Monitor

Page Type
Product Code
Definition
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Physical State
Monitor with associated electronics and patient skin electrodes.
Technical Method
abdominal EMG surface electrodes that pick up electrical activity from the uterus in labor, electrical signal converted to a monitor tracing.
Target Area
Maternal abdomen and uterus
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.2720
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.2720 External uterine contraction monitor and accessories

§ 884.2720 External uterine contraction monitor and accessories.

(a) Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

(b) Classification. Class II (performance standards).

Uterine Electromyographic Monitor

Page Type
Product Code
Definition
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Physical State
Monitor with associated electronics and patient skin electrodes.
Technical Method
abdominal EMG surface electrodes that pick up electrical activity from the uterus in labor, electrical signal converted to a monitor tracing.
Target Area
Maternal abdomen and uterus
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.2720
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.2720 External uterine contraction monitor and accessories

§ 884.2720 External uterine contraction monitor and accessories.

(a) Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

(b) Classification. Class II (performance standards).