FDA 510(k)

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

Номер K: K190539 · 2019-10-22

Дата решения2019-10-22

Код продуктаFMG

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Monumedical, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K190539. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Monumedical, LLC. The 510(k) number is K190539.

When did TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile receive FDA 510(k) clearance?

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile received FDA 510(k) clearance on 2019-10-22, under 510(k) number K190539.

Who is the listed applicant for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

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

What is the FDA product code for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

The FDA product code for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is FMG.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FMG)

K242255Qitexio® 4-Way Stopcock (QIT014)Medex K223499Three Way Stop CockM/S Romsons International K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation K211204SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal K210516Clicky CrossYomura Technologies, Inc.K190489Elcam Stopcocks and ManifoldsElcam Medical Acal

Официальный источник

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