FDA 510(k)

SafeT T-Piece Resuscitator

Номер K: K173373 · 2018-11-16

ЗаявительVentlab, LLC

Дата решения2018-11-16

Код продуктаBTL

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

SafeT T-Piece Resuscitator is the device name listed in this FDA 510(k) record. The listed applicant is Ventlab, LLC. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K173373. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SafeT T-Piece Resuscitator?

SafeT T-Piece Resuscitator is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Ventlab, LLC. The 510(k) number is K173373.

When did SafeT T-Piece Resuscitator receive FDA 510(k) clearance?

SafeT T-Piece Resuscitator received FDA 510(k) clearance on 2018-11-16, under 510(k) number K173373.

Who is the listed applicant for SafeT T-Piece Resuscitator?

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

What is the FDA product code for SafeT T-Piece Resuscitator?

The FDA product code for SafeT T-Piece Resuscitator is BTL.

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: BTL)

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical K161420MOVES SLCThornhill Research, Inc.

Официальный источник

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