FDA 510(k)

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K-번호: K180021 · 2018-06-29

신청자Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap

결정일2018-06-29

제품 코드IYE

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

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기기 요약

Proton Positioing and Immobilization Devices is the device name listed in this FDA 510(k) record. The listed applicant is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180021. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Proton Positioing and Immobilization Devices?

Proton Positioing and Immobilization Devices is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. The 510(k) number is K180021.

When did Proton Positioing and Immobilization Devices receive FDA 510(k) clearance?

Proton Positioing and Immobilization Devices received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180021.

Who is the listed applicant for Proton Positioing and Immobilization Devices?

The FDA 510(k) record lists Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proton Positioing and Immobilization Devices?

The FDA product code for Proton Positioing and Immobilization Devices is IYE.

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기기 요약

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관련 임상시험

관련 기기 (코드: IYE)

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