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FDA 510(k)

MEDO-甲状腺

K 號:K203502 · 2021-04-23

決定日期2021-04-23
產品代碼QIH
諮詢委員會RA
決定相當於

器材摘要

MEDO-Thyroid is the device name listed in this FDA 510(k) record. The listed applicant is Medo DX Pte. , Ltd.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K203502. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEDO-Thyroid?

MEDO-Thyroid is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Medo DX Pte. , Ltd.. The 510(k) number is K203502.

When did MEDO-Thyroid receive FDA 510(k) clearance?

MEDO-Thyroid received FDA 510(k) clearance on 2021-04-23, under 510(k) number K203502.

Who is the listed applicant for MEDO-Thyroid?

The FDA 510(k) record lists Medo DX Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDO-Thyroid?

The FDA product code for MEDO-Thyroid is QIH.

相關臨床試驗

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相關器械(代碼:QIH)

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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