FDA 510(k)

SafeT T-Piece Resuscitator

K-Number: K173373 · 2018-11-16

Decision Date2018-11-16

Product CodeBTL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Ventlab, LLC. The 510(k) number is K173373.

When was SafeT T-Piece Resuscitator approved by the FDA?

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

What company makes SafeT T-Piece Resuscitator?

SafeT T-Piece Resuscitator is manufactured by Ventlab, LLC.

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

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

Related Clinical Trials

NCT06849596 Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates RECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.