FDA 510(k)

Artemis二極雷射系統（RL-S20S-TWC, RL-S20S-810B, RL-S20S-755）

K 號：K233756 · 2024-02-02

決定日期2024-02-02

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is the device name listed in this FDA 510(k) record. The listed applicant is Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K233756. 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.

常見問題

What is the Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)?

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Rhein Laser Technologies Co., Ltd.. The 510(k) number is K233756.

When did Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) receive FDA 510(k) clearance?

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) received FDA 510(k) clearance on 2024-02-02, under 510(k) number K233756.

Who is the listed applicant for Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)?

FDA 510(k) 記錄將 Rhein Laser Technologies Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)?

The FDA product code for Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is GEX. This falls under the Gastroenterology category.

其他以 Rhein Laser Technologies Co., Ltd. 為申請人之記錄

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官方來源

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