FDA 510(k)

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K-번호: K231101 · 2023-06-29

결정일2023-06-29

제품 코드EZL

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

Flume Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Flume Catheter Company, Ltd.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231101. 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 Flume Catheter?

Flume Catheter is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Flume Catheter Company, Ltd.. The 510(k) number is K231101.

When did Flume Catheter receive FDA 510(k) clearance?

Flume Catheter received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231101.

Who is the listed applicant for Flume Catheter?

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

What is the FDA product code for Flume Catheter?

The FDA product code for Flume Catheter is EZL.

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기기 요약

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관련 임상시험

관련 기기 (코드: EZL)

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