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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computerized behavioral therapy device for depressive disorders.
Regulation Description Computerized behavioral therapy device for psychiatric disorders.
Definition The device is intended to provide computerized behavioral therapy to treat depressive disorders.
Product CodeSAP
Regulation Number 882.5801
Device Class 2


Premarket Reviews
ManufacturerDecision
CURIO DIGITAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTSUKA AMERICA PHARMACEUTICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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