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Found 8 results
510(k) Data Aggregation
K Number
K012404Device Name
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
Manufacturer
KATECHO, INC.
Date Cleared
2001-10-12
(74 days)
Product Code
DRO
Regulation Number
870.5550Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.
Device Description
Katecho KDP-85 Adult Defib/Pace Multifunction Electrode. The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin.
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K Number
K010543Device Name
KM-30 TENS ELECTRODE
Manufacturer
KATECHO, INC.
Date Cleared
2001-05-23
(89 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003228Device Name
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
Manufacturer
KATECHO, INC.
Date Cleared
2000-12-14
(59 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002806Device Name
K-DEFIB/PACE, MODEL KDP-60A
Manufacturer
KATECHO, INC.
Date Cleared
2000-11-21
(74 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000870Device Name
KM-10 TENS ELECTRODE
Manufacturer
KATECHO, INC.
Date Cleared
2000-11-07
(232 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993745Device Name
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
Manufacturer
KATECHO, INC.
Date Cleared
2000-02-03
(90 days)
Product Code
MKJ, NOV
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Katecho External Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-80 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) card1ac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). The Katecho KDP-80 Defilb/Pace Electrodes are designed for, and to be used interchangeably with Physio Control Defibrillation Devices that use Quik Combo Electrodes.
Device Description
KATECHO KDP-80 Defib/Pace Electrodes
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K Number
K991007Device Name
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
Manufacturer
KATECHO, INC.
Date Cleared
1999-08-23
(150 days)
Product Code
MKJ, MLN
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Katecho External Radiolucent electrode is indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KRT-60 Radiolucent electrode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum).
This device has been tested to the ANSI/AAMI DF2-1996 standard for use with equipment: Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.
Device Description
K-Defib/Pace Radio Lucent Adult Electrode Model KRT-60
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K Number
K981737Device Name
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
Manufacturer
KATECHO, INC.
Date Cleared
1998-12-09
(205 days)
Product Code
MKJ, MLN
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
KATECHO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Katecho "K-Defib/Pace Adult Electrode it is indicated for use in external Pacing. Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.
When a patient requires defibrillation or external pacing these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joulc maximum).
This device has been tested to the ANSI/AAMI DIF39-1993 standard for use with equipment by the following manufacturers; Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.
Device Description
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