FDA 510(k)

Q-Switched Nd:YAGレーザーシステム

K番号: K190936 · 2019-06-17

申請者Shanghai Apolo Medical Technology Co., Ltd.

決定日2019-06-17

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

Q-Switched Nd: YAG Laser System 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 2019-06-17 under 510(k) number K190936. 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 Q-Switched Nd: YAG Laser System?

Q-Switched Nd: YAG Laser System is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K190936.

When did Q-Switched Nd: YAG Laser System receive FDA 510(k) clearance?

Q-Switched Nd: YAG Laser System received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190936.

Who is the listed applicant for Q-Switched Nd: YAG Laser System?

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 Q-Switched Nd: YAG Laser System?

The FDA product code for Q-Switched Nd: YAG Laser System 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

K260256Q-Switched Nd:YAGレーザーシステム K260017ピコ秒Nd:YAGレーザーシステム（モデル：HS-298）K251031ファイバーラーゼ治療システム（HS-232、HS-233）K232409電磁刺激システム K221770ファイバーラーゼ治療システム K203395プラットフォーム治療システム

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公式ソース

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