FDA 510(k)

플루어플로 시스템과 플로우글라이드 엑스트라 드레인 길이

K-번호: K182067 · 2018-08-14

결정일2018-08-14

제품 코드OTK

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

PleuraFlow System with FlowGlide Extra Drainage Length is the device name listed in this FDA 510(k) record. The listed applicant is Clearflow, Inc.. It received FDA 510(k) clearance on 2018-08-14 under 510(k) number K182067. The device is classified under product code OTK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PleuraFlow System with FlowGlide Extra Drainage Length?

PleuraFlow System with FlowGlide Extra Drainage Length is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Clearflow, Inc.. The 510(k) number is K182067.

When did PleuraFlow System with FlowGlide Extra Drainage Length receive FDA 510(k) clearance?

PleuraFlow System with FlowGlide Extra Drainage Length received FDA 510(k) clearance on 2018-08-14, under 510(k) number K182067.

Who is the listed applicant for PleuraFlow System with FlowGlide Extra Drainage Length?

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

What is the FDA product code for PleuraFlow System with FlowGlide Extra Drainage Length?

The FDA product code for PleuraFlow System with FlowGlide Extra Drainage Length is OTK.

Clearflow, Inc.를 신청인으로 등재한 기타 기록

K203394PleuraFlow 시스템과 FlowGlide K191733플루라플로우 시스템을 위한 ZIP 액세서리 셔틀 K163139PleuraFlow 시스템과 FlowGlide K153681플루라플로우 시스템

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