FDA 510(k)

Steriking® LT-Blueline 袋裝 Tyvek®

K 號：K231996 · 2023-09-07

決定日期2023-09-07

產品代碼FRG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Steriking® LT-Blueline Pouches with Tyvek® is the device name listed in this FDA 510(k) record. The listed applicant is Wipak OY. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231996. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Steriking® LT-Blueline Pouches with Tyvek®?

Steriking® LT-Blueline Pouches with Tyvek® is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Wipak OY. The 510(k) number is K231996.

When did Steriking® LT-Blueline Pouches with Tyvek® receive FDA 510(k) clearance?

Steriking® LT-Blueline Pouches with Tyvek® received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231996.

Who is the listed applicant for Steriking® LT-Blueline Pouches with Tyvek®?

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

What is the FDA product code for Steriking® LT-Blueline Pouches with Tyvek®?

The FDA product code for Steriking® LT-Blueline Pouches with Tyvek® is FRG.

其他以 Wipak OY 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。

K232625Steriking® 選擇式外罩用於機械儀器 K231999Steriking® LT-Blueline 袋裝 Tyvek®K221379Steriking LT-Blueline 袋裝 Tyvek K221377SteriKing LT-Blueline 袋裝，配Tyvek K221016醫療設備包裝標籤 K210810醫療設備包裝標籤

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相關器械（代碼：FRG）

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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