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510(k) Data Aggregation
K Number
K072014Device Name
VITASCORE
Manufacturer
VITASCORE B.V.
Date Cleared
2007-11-08
(108 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
VITASCORE B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders.
The Vitascore software is intended to be used for analysis (semi-automatic and manual rescoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders.
Vitascore is to be used under supervision of a physician.
Device Description
Vitascore is a software program to
- score respiratory events
- score sleep stages and arousal
- indicate markers as for lights off/on
- produce customizable statistical reports.
Vitascore acts on
- long-term recordings that include all physiological signals that are required for clinical PolySomnoGraphy according to established standards for subsequent
- diagnosis of sleep- and sleep-related disorders.
Vitascore includes
- a workflow concept to handle the processing of sleep recordings
- optionally: automatic pre-scoring of respiratory events and sleep and arousal and EEG frequency analysis. This pre-analysis yields particular summary trend curves that facilitate the manual re-scoring.
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