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510(k) Data Aggregation
K Number
K021132Device Name
UNI-PATCH ULTRASOUND COUPLING GEL
Manufacturer
THE LUDLOW COMPANY LP
Date Cleared
2002-05-15
(36 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
THE LUDLOW COMPANY LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin
Device Description
Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.
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K Number
K012218Device Name
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
Manufacturer
THE LUDLOW COMPANY LP
Date Cleared
2001-10-12
(88 days)
Product Code
DRO
Regulation Number
870.5550Why did this record match?
Applicant Name (Manufacturer) :
THE LUDLOW COMPANY LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring.
The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only.
The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.
Device Description
Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes
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