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510(k) Data Aggregation
K Number
K170825Device Name
SnoreRx
Manufacturer
Apnea Sciences Corporation
Date Cleared
2017-08-18
(151 days)
Product Code
LRK, REG
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Apnea Sciences Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Device Description
The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. 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.
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K Number
K153200Device Name
SnoreRx
Manufacturer
Apnea Sciences Corporation
Date Cleared
2016-08-09
(279 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Apnea Sciences Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Device Description
The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. 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.
Ask a Question
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