FDA 510(k)

清晰噴射針鞘

K 號：K181690 · 2018-12-21

決定日期2018-12-21

產品代碼FBK

諮詢委員會GU

決定相當於

器材摘要

Clear-Jet Injection Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K181690. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Clear-Jet Injection Catheter?

Clear-Jet Injection Catheter is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K181690.

When did Clear-Jet Injection Catheter receive FDA 510(k) clearance?

Clear-Jet Injection Catheter received FDA 510(k) clearance on 2018-12-21, under 510(k) number K181690.

Who is the listed applicant for Clear-Jet Injection Catheter?

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

What is the FDA product code for Clear-Jet Injection Catheter?

The FDA product code for Clear-Jet Injection Catheter is FBK.

其他以 Finemedix Co., Ltd. 為申請人之記錄

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官方來源

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