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510(k) K231209

Rejoyn by Otsuka America Pharmaceutical, Inc. — Product Code SAP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 30, 2024
Date Received: April 27, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Computerized Behavioral Therapy Device For Depressive Disorders.
Device Class: Class II
Regulation Number: 882.5801
Review Panel: NE
Submission Type

The device is intended to provide computerized behavioral therapy to treat depressive disorders.