FDA 510(k)

皮膚ケア

K番号: K152736 · 2016-02-25

決定日2016-02-25

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

SKIN CARE is the device name listed in this FDA 510(k) record. The listed applicant is C.I.S, Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152736. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the SKIN CARE?

SKIN CARE is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is C.I.S, Ltd.. The 510(k) number is K152736.

When did SKIN CARE receive FDA 510(k) clearance?

SKIN CARE received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152736.

Who is the listed applicant for SKIN CARE?

The FDA 510(k) record lists C.I.S, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIN CARE?

The FDA product code for SKIN CARE is GEX. This falls under the Gastroenterology category.

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医療機器の概要

よくある質問

関連機器（コード：GEX）

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