FDA 510(k)

ComfortGuard Plus 外科袍，i500，ComfortGuard 外科袍，i500

K 號：K162442 · 2016-12-12

申請人Gri Medical & Electrical Technology Co., Ltd.

決定日期2016-12-12

產品代碼FYA

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

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162442. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K162442.

When did ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 receive FDA 510(k) clearance?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162442.

Who is the listed applicant for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA 510(k) record lists Gri Medical & Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is FYA.

其他以 Gri Medical & Electrical Technology Co., Ltd. 為申請人之記錄

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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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