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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Breath Sound Device
510(k) Number K131285
Device Name SONOSENTRY
Applicant
Isonea, Ltd.
6965 El Camino Real
Suite 105-428
Carlsbad,  CA  92009
Applicant Contact KORINA AKHONDZADEH
Correspondent
Isonea, Ltd.
6965 El Camino Real
Suite 105-428
Carlsbad,  CA  92009
Correspondent Contact KORINA AKHONDZADEH
Regulation Number868.1900
Classification Product Code
PHZ  
Date Received05/06/2013
Decision Date 08/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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