FDA 510(k)

Rejoyn

K-Number: K231209 · 2024-03-30

ApplicantOtsuka America Pharmaceutical, Inc.

Decision Date2024-03-30

Product CodeSAP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Rejoyn 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 2024-03-30 under 510(k) number K231209. The device is classified under product code SAP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rejoyn?

Rejoyn is a medical device that received FDA 510(k) clearance on 2024-03-30. The listed applicant is Otsuka America Pharmaceutical, Inc.. The 510(k) number is K231209.

When did Rejoyn receive FDA 510(k) clearance?

Rejoyn received FDA 510(k) clearance on 2024-03-30, under 510(k) number K231209.

Who is the listed applicant for Rejoyn?

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 Rejoyn?

The FDA product code for Rejoyn is SAP.

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.

K251088Otsuka Digital Feedback Device K223463Otsuka Digital Feedback Device-RW

Related Devices (Code: SAP)

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Official Source

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