FDA 510(k)

MULA (K2-A1)

K 號：K240314 · 2024-08-21

申請人Guangzhou Ciellulu Photoelectric Technology Co., Ltd.

決定日期2024-08-21

產品代碼ONF

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

MULA (K2-A1) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ciellulu Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K240314. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MULA (K2-A1)?

MULA (K2-A1) is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Guangzhou Ciellulu Photoelectric Technology Co., Ltd.. The 510(k) number is K240314.

When did MULA (K2-A1) receive FDA 510(k) clearance?

MULA (K2-A1) received FDA 510(k) clearance on 2024-08-21, under 510(k) number K240314.

Who is the listed applicant for MULA (K2-A1)?

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

What is the FDA product code for MULA (K2-A1)?

The FDA product code for MULA (K2-A1) is ONF.

相關器械（代碼：ONF）

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