FDA 510(k)

Sorbact 泡沫柔邊，Sorbact 超強吸水

K 號：K153674 · 2016-07-01

決定日期2016-07-01

產品代碼FRO

決定相當於

器材摘要

Sorbact Foam Gentle Border, Sorbact Superabsorbent is the device name listed in this FDA 510(k) record. The listed applicant is Abigo Medical AB. It received FDA 510(k) clearance on 2016-07-01 under 510(k) number K153674. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Sorbact Foam Gentle Border, Sorbact Superabsorbent?

Sorbact Foam Gentle Border, Sorbact Superabsorbent is a medical device that received FDA 510(k) clearance on 2016-07-01. The listed applicant is Abigo Medical AB. The 510(k) number is K153674.

When did Sorbact Foam Gentle Border, Sorbact Superabsorbent receive FDA 510(k) clearance?

Sorbact Foam Gentle Border, Sorbact Superabsorbent received FDA 510(k) clearance on 2016-07-01, under 510(k) number K153674.

Who is the listed applicant for Sorbact Foam Gentle Border, Sorbact Superabsorbent?

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

What is the FDA product code for Sorbact Foam Gentle Border, Sorbact Superabsorbent?

The FDA product code for Sorbact Foam Gentle Border, Sorbact Superabsorbent is FRO. This falls under the Anesthesiology category.

其他以 Abigo Medical AB 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。

K171225Sorbact 黏膜敷料-繩狀紗布

相關器械（代碼：FRO）

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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