FDA 510(k)

Rejoyn

K号: K231209 · 2024-03-30

决定日期2024-03-30

产品代码SAP

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决定实质等同

器械摘要

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.

常见问题

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.

列明Otsuka America Pharmaceutical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251088Otsuka数字反馈设备 K223463Otsuka数字反馈设备-RW

官方来源

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