FDA 510(k)

Q-Switched Nd:YAGレーザー治療システム

K番号: K163123 · 2017-02-02

申請者Beijing Sincoheren Science and Technology Development Co.

決定日2017-02-02

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 Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K163123. 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 Therapy Systems?

Q-Switched Nd:YAG Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. The 510(k) number is K163123.

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

Q-Switched Nd:YAG Laser Therapy Systems received FDA 510(k) clearance on 2017-02-02, under 510(k) number K163123.

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

The FDA 510(k) record lists Beijing Sincoheren Science and Technology Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-Switched Nd:YAG Laser Therapy Systems?

The FDA product code for Q-Switched Nd:YAG Laser Therapy Systems is GEX. This falls under the Gastroenterology category.

申請者としてBeijing Sincoheren Science and Technology Development Co.を記載するその他の記録

K162398CO2レーザー治療システム

公式ソース

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