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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K150102
Device Name SnoreSounds
Applicant
Appian Medical, Inc.
502 Scrimshaw Way
Severna Park,  MD  21146
Applicant Contact MICHAEL J THOMAS
Correspondent
Michael S. Righter
P.O. Box 63
Tolovana Park,  OR  97145
Correspondent Contact MICHAEL RIGHTER
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/20/2015
Decision Date 11/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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