FDA 510(k)

NPseal

K 號：K211130 · 2021-05-14

決定日期2021-05-14

產品代碼OKO

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

NPseal is the device name listed in this FDA 510(k) record. The listed applicant is Guard Medical, Inc.. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K211130. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NPseal?

NPseal is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Guard Medical, Inc.. The 510(k) number is K211130.

When did NPseal receive FDA 510(k) clearance?

NPseal received FDA 510(k) clearance on 2021-05-14, under 510(k) number K211130.

Who is the listed applicant for NPseal?

The FDA 510(k) record lists Guard Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NPseal?

The FDA product code for NPseal is OKO.

其他以 Guard Medical, Inc. 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。

K251156NPseal K250708NPseal K241522NPseal (20及25)K240244NPseal（小號、中號、大號）K212971NPseal K200305NPseal

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相關器械（代碼：OKO）

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。

K254160負壓治療傷口療法系統 VacHealVacHeal, LLC K251156NPsealGuard Medical, Inc.K250708NPsealGuard Medical, Inc.K241522NPseal (20及25)Guard Medical, Inc.K240244NPseal（小號、中號、大號）Guard Medical, Inc.K212971NPsealGuard Medical, Inc.

官方來源

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