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510(k) Data Aggregation
K Number
K073269Device Name
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
Manufacturer
Date Cleared
2008-04-18
(149 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
HYPNOCORE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.
Device Description
HypnoCore's HC1000P is a sleep diagnosis software application. This software is used as an aid in the diagnosis of sleep and sleep related breathing disorders. The HC1000P is able to acomplish this by analyzing continuous ECG and pulse oxygen saturation data acquired from a sleeping patient. The interpretation of the results provided by the HC1000P software package is performed in conjunction with clinical information and examination of the patient obtained by a trained professional familiar with sleep medicine.
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