FDA 510(k)

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

K-번호: K230140 · 2023-04-24

결정일2023-04-24

제품 코드MWP

자문 위원회RA

결정Substantially Equivalent

기기 요약

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is the device name listed in this FDA 510(k) record. The listed applicant is Compai Healthcare (Suzhou) Co.,Ltd. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K230140. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)?

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Compai Healthcare (Suzhou) Co.,Ltd. The 510(k) number is K230140.

When did TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) receive FDA 510(k) clearance?

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) received FDA 510(k) clearance on 2023-04-24, under 510(k) number K230140.

Who is the listed applicant for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)?

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

What is the FDA product code for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)?

The FDA product code for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) is MWP.

Compai Healthcare (Suzhou) Co.,Ltd를 신청인으로 등재한 기타 기록

K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

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