FDA 510(k)

SOL-GUARD 安全拉拔按鈕系列套件

K 號：K213718 · 2022-08-30

決定日期2022-08-30

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

SOL-GUARD Safety Pull Button Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K213718. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SOL-GUARD Safety Pull Button Collection Set?

SOL-GUARD Safety Pull Button Collection Set is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K213718.

When did SOL-GUARD Safety Pull Button Collection Set receive FDA 510(k) clearance?

SOL-GUARD Safety Pull Button Collection Set received FDA 510(k) clearance on 2022-08-30, under 510(k) number K213718.

Who is the listed applicant for SOL-GUARD Safety Pull Button Collection Set?

FDA 510(k) 記錄將 Sol-Millennium Medical, Inc. 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 SOL-GUARD Safety Pull Button Collection Set?

The FDA product code for SOL-GUARD Safety Pull Button Collection Set is JKA.

其他以 Sol-Millennium Medical, Inc. 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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相關器械（代碼：JKA）

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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