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FDA 510(k)

凍結C

K 號：K182392 · 2018-10-30

申請人B.M. Tech. Worldwide Co., Ltd.
決定日期2018-10-30
產品代碼GEH
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Frozen C is the device name listed in this FDA 510(k) record. The listed applicant is B.M. Tech. Worldwide Co., Ltd.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182392. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Frozen C?

Frozen C is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is B.M. Tech. Worldwide Co., Ltd.. The 510(k) number is K182392.

When did Frozen C receive FDA 510(k) clearance?

Frozen C received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182392.

Who is the listed applicant for Frozen C?

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

What is the FDA product code for Frozen C?

The FDA product code for Frozen C is GEH.

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官方來源

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