FDA 510(k)

Presygen/si-1

K-번호: K171245 · 2018-08-09

결정일2018-08-09

제품 코드MUD

자문 위원회CV

결정Substantially Equivalent

기기 요약

Presygen/si-1 is the device name listed in this FDA 510(k) record. The listed applicant is Christie Medical Holdings, Inc.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K171245. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Presygen/si-1?

Presygen/si-1 is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Christie Medical Holdings, Inc.. The 510(k) number is K171245.

When did Presygen/si-1 receive FDA 510(k) clearance?

Presygen/si-1 received FDA 510(k) clearance on 2018-08-09, under 510(k) number K171245.

Who is the listed applicant for Presygen/si-1?

The FDA 510(k) record lists Christie Medical Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Presygen/si-1?

The FDA product code for Presygen/si-1 is MUD.

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Presygen/si-1

기기 요약

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관련 임상시험

관련 기기 (코드: MUD)

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