FDA 510(k)

Clio Prime 及 Clio Pedo

K 號：K202664 · 2020-11-06

申請人Sota Precision Optics, Inc. Dba Sota Imaging

決定日期2020-11-06

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

Clio Prime and Clio Pedo is the device name listed in this FDA 510(k) record. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K202664. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Clio Prime and Clio Pedo?

Clio Prime and Clio Pedo is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. The 510(k) number is K202664.

When did Clio Prime and Clio Pedo receive FDA 510(k) clearance?

Clio Prime and Clio Pedo received FDA 510(k) clearance on 2020-11-06, under 510(k) number K202664.

Who is the listed applicant for Clio Prime and Clio Pedo?

The FDA 510(k) record lists Sota Precision Optics, Inc. Dba Sota Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clio Prime and Clio Pedo?

The FDA product code for Clio Prime and Clio Pedo is MUH.

其他以 Sota Precision Optics, Inc. Dba Sota Imaging 為申請人之記錄

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相關器械（代碼：MUH）

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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