FDA 510(k)

쿠스토디올 HTK 용액

K-번호: K192408 · 2020-04-24

결정일2020-04-24

제품 코드KDL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Custodiol HTK Solution is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Franz Kohler Chemie GmbH. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K192408. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Custodiol HTK Solution?

Custodiol HTK Solution is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Dr. Franz Kohler Chemie GmbH. The 510(k) number is K192408.

When did Custodiol HTK Solution receive FDA 510(k) clearance?

Custodiol HTK Solution received FDA 510(k) clearance on 2020-04-24, under 510(k) number K192408.

Who is the listed applicant for Custodiol HTK Solution?

The FDA 510(k) record lists Dr. Franz Kohler Chemie GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custodiol HTK Solution?

The FDA product code for Custodiol HTK Solution is KDL.

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쿠스토디올 HTK 용액

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KDL)

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