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510(k) Data Aggregation
K Number
K013547Device Name
BABYCOM
Manufacturer
Date Cleared
2002-02-20
(119 days)
Product Code
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
PMG MEDICA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Babycom™ is meant to be applied to a woman's abdomen during pregnancy in order to measure the fetal heart rate (FHR) as a general indicator of fetal well-being.
Device Description
The Babycom™ is a fetal ultrasonic heart rate monitor that is designed to transmit and receive ultrasonic energy into and from a pregnant woman by means of continuous wave doppler echoscopy. The Babycom™ is used to represent the fetal heart rate in an immediately perceptible form, i.e., a digital display of the rate in beats per minute (bpm) and by an audible beating signal of the same rate. The Babycom™ includes a transducer module for transmitting and receiving ultrasound signals and a signal analysis, control and display module, that we refer to as the base, that carries out all the other Babycom™ functions. The Babycom™ measures the fetal heart rate by determining the doppler shift between the transmitted and received signals.
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