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FDA 510(k)

SafeT T-Piece Resuscitator

K-Number: K173373 · 2018-11-16

ApplicantVentlab, LLC
Decision Date2018-11-16
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: BTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO KgaaK221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KGK182956Puffin Lite Infant Resuscitation SystemInternational BiomedicalK161420MOVES SLCThornhill Research, Inc.

Official Source

View on FDA Database →

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

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