FDA 510(k)

Unistik® ShieldLock, Unistik VacuFlip

K 號：K223854 · 2023-06-30

決定日期2023-06-30

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Unistik® ShieldLock, Unistik VacuFlip is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K223854. 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 Unistik® ShieldLock, Unistik VacuFlip?

Unistik® ShieldLock, Unistik VacuFlip is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K223854.

When did Unistik® ShieldLock, Unistik VacuFlip receive FDA 510(k) clearance?

Unistik® ShieldLock, Unistik VacuFlip received FDA 510(k) clearance on 2023-06-30, under 510(k) number K223854.

Who is the listed applicant for Unistik® ShieldLock, Unistik VacuFlip?

The FDA 510(k) record lists Owen Mumford, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unistik® ShieldLock, Unistik VacuFlip?

The FDA product code for Unistik® ShieldLock, Unistik VacuFlip is JKA.

其他以 Owen Mumford, 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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