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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
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