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FDA 510(k)

iOrtho

K 號：K223518 · 2023-06-13

申請人Shanghai EA Medical Instruments Co., Ltd.
決定日期2023-06-13
產品代碼PNN
諮詢委員會DE
決定相當於

器材摘要

iOrtho is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai EA Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K223518. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iOrtho?

iOrtho is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Shanghai EA Medical Instruments Co., Ltd.. The 510(k) number is K223518.

When did iOrtho receive FDA 510(k) clearance?

iOrtho received FDA 510(k) clearance on 2023-06-13, under 510(k) number K223518.

Who is the listed applicant for iOrtho?

The FDA 510(k) record lists Shanghai EA Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iOrtho?

The FDA product code for iOrtho is PNN.

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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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