FDA 510(k)

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro)

K 號：K260129 · 2026-04-15

申請人Shenzhen Kaiyan Medical Equipment Co., Ltd.

決定日期2026-04-15

產品代碼OLI

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

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260129. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K260129.

When did Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) receive FDA 510(k) clearance?

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260129.

Who is the listed applicant for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

FDA 510(k) 記錄將深圳凱亞醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

The FDA product code for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is OLI.

其他以 Shenzhen Kaiyan Medical Equipment 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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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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官方來源

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