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510(k) Data Aggregation
K Number
K020390Device Name
MODIFICATION TO FETAL ASSIST
Manufacturer
HUNTLEIGH DIAGNOSTICS LTD.
Date Cleared
2002-04-19
(72 days)
Product Code
LQK
Regulation Number
884.2730Why did this record match?
Applicant Name (Manufacturer) :
HUNTLEIGH DIAGNOSTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications. The FETAL ASSIST is specifically intended for use in the following specific areas: - antenatal monitoring in the hospital, doctors office, health clinic, home or community. - External Labour monitoring. - Waterbirth monitoring using optional waterproof transducers. - Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the measurement of uterine activity for women with a history of preterm birth. - Domiciliary Non Stress Testing applications. The FETAL ASSIST is a prescription device.
Device Description
The FETAL ASSIST is a modular product that provides a portable antepartum fetal monitor that produces fetal cardiotocographs (CTGs). CTG traces are displayed in real time on the Liquid Crystal Display (LCD) which is integral to the Host Unit and can be reviewed or downloaded to an external printer and/or central location. The Assist can be powered by a stand-alone rechargeable battery pack. Alternatively, the Assist can be powered from the AC-powered supply via a power adapter.
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K Number
K002548Device Name
FETAL ASSIST
Manufacturer
HUNTLEIGH DIAGNOSTICS LTD.
Date Cleared
2001-03-06
(201 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
HUNTLEIGH DIAGNOSTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001677Device Name
BABY DOPPLEX 4000 (BD4000)
Manufacturer
HUNTLEIGH DIAGNOSTICS LTD.
Date Cleared
2000-08-14
(74 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
HUNTLEIGH DIAGNOSTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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