FDA 510(k)

LE-12CH

K 號：K220362 · 2022-03-25

決定日期2022-03-25

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

LE-12CH is the device name listed in this FDA 510(k) record. The listed applicant is Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K220362. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LE-12CH?

LE-12CH is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Caf Medical Solutions, Inc.. The 510(k) number is K220362.

When did LE-12CH receive FDA 510(k) clearance?

LE-12CH received FDA 510(k) clearance on 2022-03-25, under 510(k) number K220362.

Who is the listed applicant for LE-12CH?

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

What is the FDA product code for LE-12CH?

The FDA product code for LE-12CH is DPS.

其他以 Caf Medical Solutions, 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。

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相關器械（代碼：DPS）

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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