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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
SEVEMA PARK,  MD  21146
Applicant Contact MICHAEL J THOMAS
Correspondent
MICHAEL S. RIGHTER
PO 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
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