Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Otsuka Digital Feedback Device-RW

K-Number: K223463 · 2023-08-11

Decision Date2023-08-11
Product CodeOZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Otsuka Digital Feedback Device-RW is the device name listed in this FDA 510(k) record. The listed applicant is Otsuka America Pharmaceutical, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K223463. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Otsuka Digital Feedback Device-RW?

Otsuka Digital Feedback Device-RW is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Otsuka America Pharmaceutical, Inc.. The 510(k) number is K223463.

When did Otsuka Digital Feedback Device-RW receive FDA 510(k) clearance?

Otsuka Digital Feedback Device-RW received FDA 510(k) clearance on 2023-08-11, under 510(k) number K223463.

Who is the listed applicant for Otsuka Digital Feedback Device-RW?

The FDA 510(k) record lists Otsuka America Pharmaceutical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Otsuka Digital Feedback Device-RW?

The FDA product code for Otsuka Digital Feedback Device-RW is OZW.

Other records listing Otsuka America Pharmaceutical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OZW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.