FDA 510(k)

AC5 專用膠

K 號：K182681 · 2018-12-14

決定日期2018-12-14

產品代碼FRO

決定相當於

器材摘要

AC5 Topical Gel is the device name listed in this FDA 510(k) record. The listed applicant is Arch Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182681. 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 AC5 Topical Gel?

AC5 Topical Gel is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Arch Therapeutics, Inc.. The 510(k) number is K182681.

When did AC5 Topical Gel receive FDA 510(k) clearance?

AC5 Topical Gel received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182681.

Who is the listed applicant for AC5 Topical Gel?

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

What is the FDA product code for AC5 Topical Gel?

The FDA product code for AC5 Topical Gel is FRO. This falls under the Anesthesiology category.

其他以 Arch Therapeutics, Inc. 為申請人之記錄

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K190129AC5 專用膠

相關器械（代碼：FRO）

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官方來源

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