FDA 510(k)

CoreLite X-Ray 표본 캔들러

K-번호: K193317 · 2019-12-13

결정일2019-12-13

제품 코드MWP

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

CoreLite X-Ray Specimen Cabinet is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging Limited. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193317. 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 CoreLite X-Ray Specimen Cabinet?

CoreLite X-Ray Specimen Cabinet is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Cirdan Imaging Limited. The 510(k) number is K193317.

When did CoreLite X-Ray Specimen Cabinet receive FDA 510(k) clearance?

CoreLite X-Ray Specimen Cabinet received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193317.

Who is the listed applicant for CoreLite X-Ray Specimen Cabinet?

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

What is the FDA product code for CoreLite X-Ray Specimen Cabinet?

The FDA product code for CoreLite X-Ray Specimen Cabinet is MWP.

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CoreLite X-Ray 표본 캔들러

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MWP)

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