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FDA 510(k)

探頭蓋（YF-001, YF-002）

K 號：K240023 · 2024-03-01

申請人Shenzhen YI Fang Blister Packaging Co., Ltd.
決定日期2024-03-01
產品代碼FLL
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Probe Covers (YF-001, YF-002) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen YI Fang Blister Packaging Co., Ltd.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K240023. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Probe Covers (YF-001, YF-002)?

Probe Covers (YF-001, YF-002) is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Shenzhen YI Fang Blister Packaging Co., Ltd.. The 510(k) number is K240023.

When did Probe Covers (YF-001, YF-002) receive FDA 510(k) clearance?

Probe Covers (YF-001, YF-002) received FDA 510(k) clearance on 2024-03-01, under 510(k) number K240023.

Who is the listed applicant for Probe Covers (YF-001, YF-002)?

The FDA 510(k) record lists Shenzhen YI Fang Blister Packaging Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Probe Covers (YF-001, YF-002)?

The FDA product code for Probe Covers (YF-001, YF-002) is FLL.

相關臨床試驗

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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相關器械（代碼：FLL）

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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