FDA 510(k)

SafeT T-Piece Resuscitator

Número K: K173373 · 2018-11-16

Data da decisão2018-11-16

Código do produtoBTL

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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