FDA 510(k)

VASOVIEW HEMOPRO 延長線，VASOVIEW HEMOPRO 2 延長線，雙極延長線，固定距離，活動回電線

K 號：K191947 · 2019-09-17

決定日期2019-09-17

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K191947. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord?

VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K191947.

When did VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord receive FDA 510(k) clearance?

VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord received FDA 510(k) clearance on 2019-09-17, under 510(k) number K191947.

Who is the listed applicant for VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord?

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

What is the FDA product code for VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord?

The FDA product code for VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord is GEI.