FDA 510(k)

Tandry CMF 板系統

K 號：K220360 · 2022-11-10

決定日期2022-11-10

產品代碼JEY

諮詢委員會DE

決定相當於

器材摘要

Tandry CMF Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K220360. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tandry CMF Plate System?

Tandry CMF Plate System is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K220360.

When did Tandry CMF Plate System receive FDA 510(k) clearance?

Tandry CMF Plate System received FDA 510(k) clearance on 2022-11-10, under 510(k) number K220360.

Who is the listed applicant for Tandry CMF Plate System?

The FDA 510(k) record lists Microware Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tandry CMF Plate System?

The FDA product code for Tandry CMF Plate System is JEY.

其他以 Microware Precision Co., Ltd. 為申請人之記錄

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相關器械（代碼：JEY）

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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