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510(k) Data Aggregation
K Number
K961798Device Name
CT 200 ELECTROCARDIOGRAPH
Manufacturer
Date Cleared
1998-08-05
(818 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MACQUARIE MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display the of electrical signal produced by the heart.
Device Description
The device is a battery-operated, portable, 12 lead electrocardiograph which produces a 1, 3, 6, or 12 channel printout. Data can also be displayed on a the monitor, using computer personal application software package.
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K Number
K981951Device Name
CT 100 ELECTROCARDIOGRAPH
Manufacturer
Date Cleared
1998-07-28
(90 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MACQUARIE MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display of the electrical signal produced by the heart.
Device Description
The device is a battery-operated, portable, 12 lead electrocardiograph which produces a single channel strip chart output.
Ask a Question
Ask a specific question about this device
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