FDA 510(k)

努力Rx

K 號：K231337 · 2023-12-13

決定日期2023-12-13

產品代碼QFT

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

EndeavorRx is the device name listed in this FDA 510(k) record. The listed applicant is Akili Interactive Labs, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K231337. The device is classified under product code QFT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndeavorRx?

EndeavorRx is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Akili Interactive Labs, Inc.. The 510(k) number is K231337.

When did EndeavorRx receive FDA 510(k) clearance?

EndeavorRx received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231337.

Who is the listed applicant for EndeavorRx?

The FDA 510(k) record lists Akili Interactive Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndeavorRx?

The FDA product code for EndeavorRx is QFT.

其他以 Akili Interactive Labs, 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。

K233496努力OTC

相關器械（代碼：QFT）

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。

K243729PrismiraLumos Labs, Inc.K233496努力OTCAkili Interactive Labs, Inc.

官方來源

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