FDA 510(k)

大塚數位反饋設備-RW

K 號：K223463 · 2023-08-11

決定日期2023-08-11

產品代碼OZW

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Otsuka America Pharmaceutical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251088大塚數位反饋裝置 K231209Rejoyn

相關器械（代碼：OZW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251088大塚數位反饋裝置Otsuka America Pharmaceutical, Inc.K183052ID-Cap系統Etectrx, Inc.

官方來源

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