FDA 510(k)

980nm ダイオードレーザー治療デバイス

K番号: K191349 · 2019-08-16

申請者Shanghai Apolo Medical Technology Co., Ltd.

決定日2019-08-16

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

980nm Diode Laser Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191349. 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 980nm Diode Laser Therapy Device?

980nm Diode Laser Therapy Device is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K191349.

When did 980nm Diode Laser Therapy Device receive FDA 510(k) clearance?

980nm Diode Laser Therapy Device received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191349.

Who is the listed applicant for 980nm Diode Laser Therapy Device?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 980nm Diode Laser Therapy Device?

The FDA product code for 980nm Diode Laser Therapy Device is GEX. This falls under the Gastroenterology category.

申請者としてShanghai Apolo Medical Technology Co., Ltd.を記載するその他の記録

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公式ソース

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