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510(k) Data Aggregation
K Number
K071118Device Name
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
Manufacturer
IVES EEG SOLUTIONS, INC.
Date Cleared
2007-09-07
(140 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
IVES EEG SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The cutaneous, surface cup electrode system is intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.
Device Description
The cutaneous surface electrode (GCE, SCE, SCE, SCE' and CPES) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, gold, silver, conductive plastic, Ag-Ag/Cl, that have long been used for this intended purpose throughout the industry. The recording disc is permanently connected to a lead wire. This joint is then covered in a heat-shrink tube so as not to allow exposed lead wires and also to provide a strain relief. The lead wires are insulated with a Teflon insulation or equivalent. The lead wires are short and terminate in a small mass connector than conforms to DIN 42-802 for electrical safety. This small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802.
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K Number
K062880Device Name
SUBDERMAL WIRE ELECTRODE, MODEL SWE
Manufacturer
IVES EEG SOLUTIONS, INC.
Date Cleared
2006-12-22
(87 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
IVES EEG SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subdermal wire electrode (SWE) is intended for temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU). The SWE is a disposable, single use device. The SWE is intended for use in a similar manner to that of a subdermal needle electrode.
Device Description
Subdermal Wire Electrode (SWE)
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K Number
K060189Device Name
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
Manufacturer
IVES EEG SOLUTIONS, INC.
Date Cleared
2006-05-30
(126 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
IVES EEG SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).
The pSWE is a disposable, single use device.
The pSWE is intended for use in a similar manner to that of a subdermal needle electrode.
Device Description
Not Found
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