FDA 510(k)

MD-320W 超聲生物顯微鏡

K 號：K213070 · 2021-11-18

決定日期2021-11-18

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

MD-320W Ultrasound Biomicroscope is the device name listed in this FDA 510(k) record. The listed applicant is MEDA Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213070. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MD-320W Ultrasound Biomicroscope?

MD-320W Ultrasound Biomicroscope is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is MEDA Co., Ltd.. The 510(k) number is K213070.

When did MD-320W Ultrasound Biomicroscope receive FDA 510(k) clearance?

MD-320W Ultrasound Biomicroscope received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213070.

Who is the listed applicant for MD-320W Ultrasound Biomicroscope?

FDA 510(k) 記錄將 MEDA Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for MD-320W Ultrasound Biomicroscope?

The FDA product code for MD-320W Ultrasound Biomicroscope is IYO.

其他以 MEDA Co., Ltd. 為申請人之記錄

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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相關器械（代碼：IYO）

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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官方來源

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