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Found 7 results
510(k) Data Aggregation
K Number
K020382Device Name
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
Manufacturer
MEDICOTEST A/S
Date Cleared
2002-06-28
(143 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.
Device Description
Not Found
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K Number
K020907Device Name
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
Manufacturer
MEDICOTEST A/S
Date Cleared
2002-06-14
(86 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.
Device Description
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K Number
K002079Device Name
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
Manufacturer
MEDICOTEST A/S
Date Cleared
2001-02-22
(227 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001869Device Name
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
Manufacturer
MEDICOTEST A/S
Date Cleared
2000-09-18
(90 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983689Device Name
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
Manufacturer
MEDICOTEST A/S
Date Cleared
1999-01-15
(87 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for resting ECG.
Device Description
Not Found
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K Number
K973529Device Name
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
Manufacturer
MEDICOTEST A/S
Date Cleared
1997-11-20
(63 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
Device Description
Neuroline, Disposable Concentric Needle Electrode
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K Number
K965194Device Name
MEDICOM, TENS ELECTRODES
Manufacturer
MEDICOTEST A/S
Date Cleared
1997-03-06
(72 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
MEDICOTEST A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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