FDA 510(k)

CommandEP數據管理員PC (DPC02)，CommandEP HMD (HMD02)

K 號：K223290 · 2023-07-14

決定日期2023-07-14

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is the device name listed in this FDA 510(k) record. The listed applicant is Sentiar, Inc.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K223290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Sentiar, Inc.. The 510(k) number is K223290.

When did CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) receive FDA 510(k) clearance?

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K223290.

Who is the listed applicant for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

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

What is the FDA product code for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

The FDA product code for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is LLZ.

其他以 Sentiar, 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。

K192890設備名稱醫療設備規範文本 SentEP

相關器械（代碼：LLZ）

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。

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官方來源

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