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510(k) Data Aggregation
K Number
K082849Device Name
SILENT SLEEP
Manufacturer
Date Cleared
2009-07-16
(290 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
CRANIOFACIAL PAIN CENTER OF IDAHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. For the temporary or trial treatment of snoring and mild to moderate obstructive sleep apnea in adults over age 18. The Silent Sleep is not intended to be used for more than 30 days.
Device Description
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