Otsuka Digital Feedback Device— 510(k) K251088

Name: FDA 510(k) clearance K251088
Creator: U.S. Food and Drug Administration
Published: 2025-06-30

Substantially Equivalent

Otsuka America Pharmaceutical, Inc.

FDA 510(k) clearance K251088 for Otsuka Digital Feedback Device, Substantially Equivalent on 2025-06-30. Applicant: Otsuka America Pharmaceutical, Inc.. Device class: 2.

Clearance details

Applicant: Otsuka America Pharmaceutical, Inc.
Product code: Code OZW
Device class: Class 2
Regulation: 21 CFR 880.6305
Advisory panel: General Hospital
Date received: 2025-04-09
Decision date: 2025-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K131524 — PROTEUS PATCH INCLUDING INGESTIBLE SENSOR2013-06-23

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