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FDA 510(k)

AnyCheck IMT-100

K 號：K180953 · 2019-02-20

申請人Dms Co., Ltd.
決定日期2019-02-20
產品代碼EKX
諮詢委員會DE
決定相當於

器材摘要

AnyCheck IMT-100 is the device name listed in this FDA 510(k) record. The listed applicant is Dms Co., Ltd.. It received FDA 510(k) clearance on 2019-02-20 under 510(k) number K180953. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AnyCheck IMT-100?

AnyCheck IMT-100 is a medical device that received FDA 510(k) clearance on 2019-02-20. The listed applicant is Dms Co., Ltd.. The 510(k) number is K180953.

When did AnyCheck IMT-100 receive FDA 510(k) clearance?

AnyCheck IMT-100 received FDA 510(k) clearance on 2019-02-20, under 510(k) number K180953.

Who is the listed applicant for AnyCheck IMT-100?

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

What is the FDA product code for AnyCheck IMT-100?

The FDA product code for AnyCheck IMT-100 is EKX.

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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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官方來源

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