FDA 510(k) Application Details - K133263

Device Classification Name

  More FDA Info for this Device
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 US
Other 510(k) Applications for this Company
Contact JAFAR SHENASA
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 10/23/2013
Decision Date 02/07/2014
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact