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510(k) Data Aggregation
K Number
K123335Device Name
SUNRAY FETAL MONITOR
Manufacturer
SUNRAY MEDICAL APPARATUS CO., LTD.
Date Cleared
2013-03-21
(146 days)
Product Code
HGM, HGL
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
SUNRAY MEDICAL APPARATUS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SRF618B5 Fetal Monitor detects and displays single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Ten hours of tracing may be stored and later retrieved for printing. It is intended for antepartum use by trained healthcare personnel. It is not intended for home use.
Diagnostic ultrasound imaging or fluid flow analysis of the human body for antepartum use as follows: Fetal / Obstetrics, Mode of Operation: PWD (N)
Device Description
SRF618B5 is a fetal monitor, providing continuous monitoring, displaying, printing and recording of single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) for antepartum testing and monitoring. SRF618B5 irradiates the ultrasound wave to maternal abdomen, and detects the Doppler effect signal reflected from the heart of the fetus. SRF618B5 extracts FHR and FM from this signal and provides the fetal heart beat sound with internal speaker.
SRF618B5 measures the UA of a pregnant woman using TOCO sensor. SRF618B5 displays FHR, UA and FM with waveforms and numbers on the color LCD screen, saves them in internal flash memory and prints parts of them to review in details.
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