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FDA 510(k)

VORTRAN GO2VENT

K-Number: K162968 · 2017-04-10

ApplicantVortran Medical Technology 1, Inc.
Decision Date2017-04-10
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VORTRAN GO2VENT is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K162968. 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 VORTRAN GO2VENT?

VORTRAN GO2VENT is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K162968.

When did VORTRAN GO2VENT receive FDA 510(k) clearance?

VORTRAN GO2VENT received FDA 510(k) clearance on 2017-04-10, under 510(k) number K162968.

Who is the listed applicant for VORTRAN GO2VENT?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTRAN GO2VENT?

The FDA product code for VORTRAN GO2VENT is BTL.

Other records listing Vortran Medical Technology 1, Inc. as applicant

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.

K202219VORTRAN GO2VENT with PEEP ValveK182292VORTRAN APM-PlusK173914VORTRAN Cuff Inflator (VCI)K153733VORTRAN Manometer

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 BiomedicalK173373SafeT T-Piece ResuscitatorVentlab, LLC

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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