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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ingestible event marker
510(k) Number K133263
Device Name PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
Applicant
PROTEUS DIGITAL HEALTH, INC.
2600 BRIDGE PARKWAY, SUITE 101
REDWOOD CITY,  CA  94065
Applicant Contact JAFAR SHENASA
Correspondent
PROTEUS DIGITAL HEALTH, INC.
2600 BRIDGE PARKWAY, SUITE 101
REDWOOD CITY,  CA  94065
Correspondent Contact JAFAR SHENASA
Regulation Number880.6305
Classification Product Code
OZW  
Subsequent Product Code
DXH  
Date Received10/23/2013
Decision Date 02/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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