K-number	K223463
Device name	Otsuka Digital Feedback Device-RW
Applicant	Otsuka America Pharmaceutical, Inc.
Product code	OZW
Device class	Class II
Decision date	Aug 11, 2023
Decision	Substantially Equivalent
Regulation	880.6305

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Source

View the full FDA submission: accessdata.fda.gov

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Otsuka Digital Feedback Device-RW

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