FDA 510(k)

レーザーダイオードシステムモデルダウン-S

K番号: K243037 · 2024-12-26

申請者Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

決定日2024-12-26

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

Diode Laser System model Dawn-S is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K243037. 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 Diode Laser System model Dawn-S?

Diode Laser System model Dawn-S is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K243037.

When did Diode Laser System model Dawn-S receive FDA 510(k) clearance?

Diode Laser System model Dawn-S received FDA 510(k) clearance on 2024-12-26, under 510(k) number K243037.

Who is the listed applicant for Diode Laser System model Dawn-S?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser System model Dawn-S?

The FDA product code for Diode Laser System model Dawn-S is GEX. This falls under the Gastroenterology category.

申請者としてShanghai Wonderful Opto-Electrics Tech.Co.,Ltdを記載するその他の記録

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