FDA 510(k)

膀胱掃描儀（型號：M2、M2-W、M1、M1-W）

K 號：K190769 · 2019-05-22

決定日期2019-05-22

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Lischka Medtech Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K190769. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Suzhou Lischka Medtech Co., Ltd.. The 510(k) number is K190769.

When did Bladder Scanner (Models: M2, M2-W, M1, M1-W) receive FDA 510(k) clearance?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) received FDA 510(k) clearance on 2019-05-22, under 510(k) number K190769.

Who is the listed applicant for Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

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

What is the FDA product code for Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

The FDA product code for Bladder Scanner (Models: M2, M2-W, M1, M1-W) is IYO.

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYO）

官方來源