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510(k) DEN120011

PROTEUS INGESTION CONFINMATION SYSTEMS by Proteus Biomedical, Inc. — Product Code OZW

DEN120011 is an FDA 510(k) premarket notification submitted by Proteus Biomedical, Inc. for the device "PROTEUS INGESTION CONFINMATION SYSTEMS". The FDA issued a decision of De Novo Granted on July 10, 2012. The device falls under product code OZW (Ingestible Event Marker), a Class II device regulated under 21 CFR 880.6305. Proteus Biomedical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
July 10, 2012
Date Received
May 11, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ingestible Event Marker
Device Class
Class II
Regulation Number
880.6305
Review Panel
CV
Submission Type

To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device

Other clearances by Proteus Biomedical, Inc.

  • K093976 — RAISIN PERSONAL MONITOR (March 25, 2010)

Other clearances for product code OZW

  • K251088 — Otsuka Digital Feedback Device (June 30, 2025)
  • K223463 — Otsuka Digital Feedback Device-RW (August 11, 2023)
  • K183052 — ID-Cap System (December 6, 2019)
  • K150494 — Proteus Digital Health Feedback Device (June 27, 2015)
  • K133263 — PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) (February 7, 2014)
  • K131524 — PROTEUS PATCH INCLUDING INGESTIBLE SENSOR (June 23, 2013)
  • K131009 — PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (May 7, 2013)

FDA data resources