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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
Regulation Description 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
OTSUKA AMERICA PHARMACEUTICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

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