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510(k) Data Aggregation
K Number
K971148Device Name
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
Manufacturer
CARDIOTRONICS SYSTEMS, INC.
Date Cleared
1997-05-15
(48 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
CARDIOTRONICS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970719Device Name
700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
Manufacturer
CARDIOTRONICS SYSTEMS, INC.
Date Cleared
1997-04-16
(48 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
CARDIOTRONICS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 700-MP Series Radiolucent Multi-pad electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The MP designation refers to the multifunctionality of these electrodes wherein the separate ECG monitoring elements allow for continuous ECG monitoring through the attachment of separate ECG leadwires. The radiolucent substrate of these electrodes makes them particularly well suited for certain clinical applications involving radiographic viewing. The expected patient population for the use of these devices is primarily adults. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. Individual catalog numbers are labeled for more specific use based primarily on the interface connector and cable system which defines the host external device, such as an external defibrillator.
The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses:
- External Defibrillation External Pacing ECG Monitorina Synchonized Cardioversion
As with all electrodes of this type, labeling indicates that separate ECG electrodes are required for monitoring during external pacing. In the case of 700-MP Radiolucent Multi-Pad Electrodes these separate ECG monitoring electrodes are provided on the same foam backing for the optional attachment of separate ECG leadwires.
Device Description
The 700-MP Radiolucent Multi-Pad electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor. In addition, the 700-MP electrodes provide separate ECG monitoring elements on the same foam backing material for the attachment of standard ECG leadwires.
Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is performed in accordance with established protocols. Optionally, the separate leadwires may be attached to the ECG monitoring elements provided on the foam back area.
The 700-MP Radiolucent Multi-Pad electrodes are produced only in the Adult configuration. Leadwire sets having various lengths and interface connectors are added to the basic electrode style and may result in different catalog numbers to obtain combinations of end product design. The product line is further differentiated through trade name identification.
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K Number
K964991Device Name
700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
Manufacturer
CARDIOTRONICS SYSTEMS, INC.
Date Cleared
1997-01-15
(33 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
CARDIOTRONICS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K964469Device Name
700-F SERIES STIMULATION ELECTRODES
Manufacturer
CARDIOTRONICS SYSTEMS, INC.
Date Cleared
1996-12-11
(34 days)
Product Code
LDD
Regulation Number
870.5300Why did this record match?
Applicant Name (Manufacturer) :
CARDIOTRONICS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 700-F series electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use is to be less than 24 hours. Individual catalog numbers are labeled for more specific use based primarily on the Interface connector and cable system which defines the host external device, such as an external defibrillator.
The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labels with one or more of the following intended uses:
External Defibrillation
External Pacing
ECG Monitoring
Synchonized Cardioversion
Device Description
The 700-F Series electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor.
Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is new accordance with established protocols.
The 700-F Series electrodes are produced in two basic styles; Adult and Child. Leadwire sets having various lengths and interface connectors are added to the basic electrode styles to obtain many combinations of end product design. The product line is further differentiated through trade name and OEM identification.
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