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510(k) Data Aggregation
K Number
K041031Device Name
CARDIOSTATION-100 (CS-100)
Manufacturer
Date Cleared
2005-01-26
(280 days)
Product Code
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
US CLOVER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioStation-100 is intended to be used as an aid to diagnosis by means of analysis of cardiac electrical signals in the frequency domain, the power spectral estimate.
Device Description
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