FDA 510(k)

Urethrotech UCD

K-번호: K190060 · 2019-10-04

결정일2019-10-04

제품 코드EZL

자문 위원회GU

결정Substantially Equivalent

기기 요약

Urethrotech UCD is the device name listed in this FDA 510(k) record. The listed applicant is Urethrotech. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190060. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Urethrotech UCD?

Urethrotech UCD is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Urethrotech. The 510(k) number is K190060.

When did Urethrotech UCD receive FDA 510(k) clearance?

Urethrotech UCD received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190060.

Who is the listed applicant for Urethrotech UCD?

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

What is the FDA product code for Urethrotech UCD?

The FDA product code for Urethrotech UCD is EZL.

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Urethrotech UCD

기기 요약

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관련 임상시험

관련 기기 (코드: EZL)

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