FDA 510(k) Application Details - K131524

Device Classification Name	More FDA Info for this Device
510(K) Number	K131524
Device Name	PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
Applicant	PROTEUS DIGITAL HEALTH, INC. 2600 BRIDGE PARKWAY, SUITE 101 REDWOOD CITY, CA 94065 US Other 510(k) Applications for this Company
Contact	ZAHEDEH HATAMKHANY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2013
Decision Date	06/23/2013
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