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FDA 510(k)

CoverU一次性帶膠帶隔離衣 AAMI第4級隔離衣 CoverU一次性帶膠帶隔離衣 - 化療衣

K 號：K210414 · 2022-10-21

申請人Medtecs (Taiwan) Corp.
決定日期2022-10-21
產品代碼FYC
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

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medtecs (Taiwan) Corp.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K210414. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Medtecs (Taiwan) Corp.. The 510(k) number is K210414.

When did CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown receive FDA 510(k) clearance?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown received FDA 510(k) clearance on 2022-10-21, under 510(k) number K210414.

Who is the listed applicant for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

The FDA 510(k) record lists Medtecs (Taiwan) Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

The FDA product code for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is FYC.

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官方來源

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