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510(k) Data Aggregation
K Number
K101867Device Name
VICOR PD2I ANALYZER
Manufacturer
Date Cleared
2011-04-14
(286 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
VICOR TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV) at rest and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. The results are to be interpreted by a qualified healthcare practitioner. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
Device Description
The Vicor PD2i Analyzer is a software algorithm for measuring heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).
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K Number
K082709Device Name
VICOR PD2I ANALYZER, VERSION 2.1
Manufacturer
Date Cleared
2008-12-29
(104 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
VICOR TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
Device Description
The Vicor PD2i Analyzer is a software algorithm for recording heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).
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Ask a specific question about this device
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