FDA 510(k)

CT3000프로

K-번호: K212830 · 2021-12-21

결정일2021-12-21

제품 코드FEN

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

CT3000Pro is the device name listed in this FDA 510(k) record. The listed applicant is Srs Medical. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K212830. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CT3000Pro?

CT3000Pro is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Srs Medical. The 510(k) number is K212830.

When did CT3000Pro receive FDA 510(k) clearance?

CT3000Pro received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212830.

Who is the listed applicant for CT3000Pro?

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

What is the FDA product code for CT3000Pro?

The FDA product code for CT3000Pro is FEN.

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