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FDA 510(k)

二極雷射治療設備

K 號：K232709 · 2023-11-30

申請人Hebei Zhemai Technology Co., Ltd.
決定日期2023-11-30
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

Diode laser therapy device is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Zhemai Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K232709. 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 Diode laser therapy device?

Diode laser therapy device is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Hebei Zhemai Technology Co., Ltd.. The 510(k) number is K232709.

When did Diode laser therapy device receive FDA 510(k) clearance?

Diode laser therapy device received FDA 510(k) clearance on 2023-11-30, under 510(k) number K232709.

Who is the listed applicant for Diode laser therapy device?

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

What is the FDA product code for Diode laser therapy device?

The FDA product code for Diode laser therapy device is GEX. This falls under the Gastroenterology category.

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其他以 Hebei Zhemai Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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