FDA 510(k)

THD 直腸軟體系統

K 號：K193512 · 2020-01-26

決定日期2020-01-26

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

THD Procto Software System is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2020-01-26 under 510(k) number K193512. 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 THD Procto Software System?

THD Procto Software System is a medical device that received FDA 510(k) clearance on 2020-01-26. The listed applicant is Thd Spa. The 510(k) number is K193512.

When did THD Procto Software System receive FDA 510(k) clearance?

THD Procto Software System received FDA 510(k) clearance on 2020-01-26, under 510(k) number K193512.

Who is the listed applicant for THD Procto Software System?

The FDA 510(k) record lists Thd Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THD Procto Software System?

The FDA product code for THD Procto Software System is IYO.

其他以 Thd Spa 為申請人之記錄

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相關器械（代碼：IYO）

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官方來源

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