FDA 510(k) Application Details - K131009

Device Classification Name

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510(K) Number K131009
Device Name PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
Applicant PROTEUS DIGITAL HEALTH, INC.
2600 BRIDGE PARKWAY, SUITE 101
REDWOOD CITY, CA 94065 US
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Contact JAFAR SHENASA
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Regulation Number

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Classification Product Code OZW
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Date Received 04/11/2013
Decision Date 05/07/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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