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510(k) Data Aggregation
K Number
K113569Device Name
APNEARX
Manufacturer
APNEA SCIENCE CORPORATION
Date Cleared
2012-03-01
(90 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
APNEA SCIENCE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apnea Sciences Corporation "ApneaRx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
Device Description
The Apnea Sciences Corporation ApneaRx is an intraoral device used at night to reduce mild to moderate obstructive sleep apnea, and/or snoring by advancing the lower jaw (mandibular repositioning) and thereby minimizing air obstruction and turbulence. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep.
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