FDA 510(k)

Alevicyn SG 抗菌膠

K 號：K171935 · 2017-12-01

決定日期2017-12-01

產品代碼FRO

決定相當於

器材摘要

Alevicyn SG Antimicrobial Gel is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K171935. 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 Alevicyn SG Antimicrobial Gel?

Alevicyn SG Antimicrobial Gel is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K171935.

When did Alevicyn SG Antimicrobial Gel receive FDA 510(k) clearance?

Alevicyn SG Antimicrobial Gel received FDA 510(k) clearance on 2017-12-01, under 510(k) number K171935.

Who is the listed applicant for Alevicyn SG Antimicrobial Gel?

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

What is the FDA product code for Alevicyn SG Antimicrobial Gel?

The FDA product code for Alevicyn SG Antimicrobial Gel is FRO. This falls under the Anesthesiology category.

其他以 Sonoma Pharmaceuticals, 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。

K261023微達辛傷口灌洗溶液 K240510微達辛水膠 K233399微達辛傷口護理溶液 K173896微克辛抗菌水凝胶 K172851微克辛加抗菌傷口護理溶液

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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。