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510(k) Data Aggregation
K Number
K100185Device Name
SLEEP APP
Manufacturer
Date Cleared
2010-11-19
(301 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
SLEEP MEDICINE NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SleepApp™ is intended for the treatment of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.
Device Description
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