FDA 510(k)

폐쇄형 요도 Foley baloon 캐터터

K-번호: K201776 · 2020-12-30

결정일2020-12-30

제품 코드EZL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Foley Balloon Catheter for Urology is the device name listed in this FDA 510(k) record. The listed applicant is Apollon Co., Ltd.. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K201776. 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 Foley Balloon Catheter for Urology?

Foley Balloon Catheter for Urology is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Apollon Co., Ltd.. The 510(k) number is K201776.

When did Foley Balloon Catheter for Urology receive FDA 510(k) clearance?

Foley Balloon Catheter for Urology received FDA 510(k) clearance on 2020-12-30, under 510(k) number K201776.

Who is the listed applicant for Foley Balloon Catheter for Urology?

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

What is the FDA product code for Foley Balloon Catheter for Urology?

The FDA product code for Foley Balloon Catheter for Urology is EZL.

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폐쇄형 요도 Foley baloon 캐터터

기기 요약

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관련 임상시험

관련 기기 (코드: EZL)

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