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510(k) Data Aggregation
K Number
K971818Device Name
SNOREX
Manufacturer
Date Cleared
1997-12-18
(216 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
SNOREX (NZ) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The use of the SNOREX device is indicated for anyone who snores, has a desire to alleviate or eliminate snoring, and has sufficient natural upper and lower teeth to hold the appliance in place while sleeping.
Device Description
The SNOREX is a custom formed mandibular splint designed to hold the lower jaw in a forward position while sleeping.
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