FDA 510(k) Applications Submitted by Otsuka America Pharmaceutical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K251088 04/09/2025 Otsuka Digital Feedback Device Otsuka America Pharmaceutical, Inc.
K231209 04/27/2023 Rejoyn Otsuka America Pharmaceutical, Inc.
K223463 11/16/2022 Otsuka Digital Feedback Device-RW Otsuka America Pharmaceutical, Inc.


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