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510(k) Data Aggregation
K Number
K982843Device Name
CMS-2000
Manufacturer
Date Cleared
1998-11-10
(90 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CMS-2000 is intended to be used in the recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders, which principally include cardiac arrhythmia and myocardial ischemia. This recorder will document and compress the electrocardiograph signal into a memory card during 24 hours recording period with a patient.
Device Description
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