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FDA 510(k)

Sim&Size

K 號:K202322 · 2020-12-31

申請人Sim&Cure
決定日期2020-12-31
產品代碼PZO
諮詢委員會RA
決定相當於

器材摘要

Sim&Size is the device name listed in this FDA 510(k) record. The listed applicant is Sim&Cure. It received FDA 510(k) clearance on 2020-12-31 under 510(k) number K202322. The device is classified under product code PZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sim&Size?

Sim&Size is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is Sim&Cure. The 510(k) number is K202322.

When did Sim&Size receive FDA 510(k) clearance?

Sim&Size received FDA 510(k) clearance on 2020-12-31, under 510(k) number K202322.

Who is the listed applicant for Sim&Size?

The FDA 510(k) record lists Sim&Cure as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sim&Size?

The FDA product code for Sim&Size is PZO.

其他以 Sim&Cure 為申請人之記錄

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相關器械(代碼:PZO)

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。

官方來源

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