FDA 510(k)

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K-번호: K171673 · 2018-01-19

결정일2018-01-19

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

Focus Cap is the device name listed in this FDA 510(k) record. The listed applicant is Gce Medical Corporation. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K171673. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Focus Cap?

Focus Cap is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Gce Medical Corporation. The 510(k) number is K171673.

When did Focus Cap receive FDA 510(k) clearance?

Focus Cap received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171673.

Who is the listed applicant for Focus Cap?

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

What is the FDA product code for Focus Cap?

The FDA product code for Focus Cap is FDF.

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기기 요약

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관련 임상시험

관련 기기 (코드: FDF)

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