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510(k) K131009

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) by Proteus Digital Health, Inc. — Product Code OZW

K131009 is an FDA 510(k) premarket notification submitted by Proteus Digital Health, Inc. for the device "PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)". The FDA issued a decision of Substantially Equivalent on May 7, 2013. The device falls under product code OZW (Ingestible Event Marker), a Class II device regulated under 21 CFR 880.6305. Proteus Digital Health, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2013
Date Received
April 11, 2013
Clearance Type
Special
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 Digital Health, Inc.

  • 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)

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)
  • DEN120011 — PROTEUS INGESTION CONFINMATION SYSTEMS (July 10, 2012)

FDA data resources