FDA 510(k)

T3 平台軟體

K 號：K213423 · 2023-01-06

決定日期2023-01-06

產品代碼PLB

諮詢委員會履歷

決定相當於

器材摘要

T3 Platform software is the device name listed in this FDA 510(k) record. The listed applicant is Etiometry, Inc.. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K213423. The device is classified under product code PLB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the T3 Platform software?

T3 Platform software is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Etiometry, Inc.. The 510(k) number is K213423.

When did T3 Platform software receive FDA 510(k) clearance?

T3 Platform software received FDA 510(k) clearance on 2023-01-06, under 510(k) number K213423.

Who is the listed applicant for T3 Platform software?

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

What is the FDA product code for T3 Platform software?

The FDA product code for T3 Platform software is PLB.

其他以 Etiometry, 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。

K254066Etiometry 平台 K241479Etiometry 平台 (DAV 5.4 RAE 9.2)K223578T3 平台軟體 K213230T3 平台軟體 K202306T3 平台軟體 K190273T3 平台軟體

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相關器械（代碼：PLB）

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。

K240756AITRICS-VCAitrics Co., Ltd.K240558NAVOYCDSAlgodx AB K230386SpassageQSpass, Inc.K183282生物生命數據分析引擎Biofourmis Singapore Pte., Ltd.K152258T3軟體Etiometry, Inc.

官方來源

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