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510(k) Data Aggregation
K Number
K030379Device Name
APLAB, MODEL 801D0030
Manufacturer
SECTOR MEDICAL CORP.
Date Cleared
2003-08-29
(205 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
SECTOR MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ApLab is intended for use in recording respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.
Device Description
The ApLab is a re-usable, respiratory pressure sensor system intended to provide a recording of respiratory pressure during sleep. This physician prescribed device will provide a screening index for and aid in the diagnosis of obstructive sleep apnea syndrome. The device is about the size of a common beeper that contains proprietary electronic circuitry and embedded software. The ApLab utilizes a disposable, lightweight plastic nasal cannula that can be conveniently worn while sleeping at home. At completion of a sleep study the device is returned for data analysis and report generation.
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