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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ingestible event marker
Definition 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
Product CodeOZW
Regulation Number 880.6305
Device Class 2


Premarket Reviews
ManufacturerDecision
ETECTRX, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTSUKA AMERICA PHARMACEUTICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROTEUS BIOMEDICAL, INC.
  GRANTED 1
PROTEUS DIGITAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K131009  PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
  2.  K131524  PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
  3.  K133263  PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSOR ...
  4.  K150494  Proteus Digital Health Feedback Device

MDR Year MDR Reports MDR Events
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 2 2

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