FDA 510(k)

一次性无菌針刺器

K 號：K222055 · 2022-11-15

申請人Tianjin Rilifine Medical Device Co., Ltd.

決定日期2022-11-15

產品代碼FMK

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

Disposable Sterile Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Rilifine Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K222055. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Sterile Lancet?

Disposable Sterile Lancet is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Tianjin Rilifine Medical Device Co., Ltd.. The 510(k) number is K222055.

When did Disposable Sterile Lancet receive FDA 510(k) clearance?

Disposable Sterile Lancet received FDA 510(k) clearance on 2022-11-15, under 510(k) number K222055.

Who is the listed applicant for Disposable Sterile Lancet?

The FDA 510(k) record lists Tianjin Rilifine Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Sterile Lancet?

The FDA product code for Disposable Sterile Lancet is FMK.

其他以 Tianjin Rilifine Medical Device 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。

K222246一次性无菌針刺器

相關器械（代碼：FMK）

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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