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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K100185
Device Name SLEEP APP
Applicant
Sleep Medicine Network, Inc.
7931 NE Halsey Suite 305
Portland,  OR  97213
Applicant Contact RICHARD MOORE
Correspondent
Sleep Medicine Network, Inc.
7931 NE Halsey Suite 305
Portland,  OR  97213
Correspondent Contact RICHARD MOORE
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/22/2010
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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