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510(k) K223463

Otsuka Digital Feedback Device-RW by Otsuka America Pharmaceutical, Inc. — Product Code OZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2023
Date Received
November 16, 2022
Clearance Type
Traditional
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 Otsuka America Pharmaceutical, Inc.

  • K251088 — Otsuka Digital Feedback Device (June 30, 2025)
  • K231209 — Rejoyn (March 30, 2024)

Other clearances for product code OZW

  • K251088 — Otsuka Digital Feedback Device (June 30, 2025)
  • 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)
  • DEN120011 — PROTEUS INGESTION CONFINMATION SYSTEMS (July 10, 2012)