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FDA 510(k)

Oxymag - Transport and Emergency Ventilator

K-Number: K221634 · 2023-05-24

ApplicantMagnamed Tecnologia Medica S/A
Decision Date2023-05-24
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxymag - Transport and Emergency Ventilator is the device name listed in this FDA 510(k) record. The listed applicant is Magnamed Tecnologia Medica S/A. It received FDA 510(k) clearance on 2023-05-24 under 510(k) number K221634. 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 Oxymag - Transport and Emergency Ventilator?

Oxymag - Transport and Emergency Ventilator is a medical device that received FDA 510(k) clearance on 2023-05-24. The listed applicant is Magnamed Tecnologia Medica S/A. The 510(k) number is K221634.

When did Oxymag - Transport and Emergency Ventilator receive FDA 510(k) clearance?

Oxymag - Transport and Emergency Ventilator received FDA 510(k) clearance on 2023-05-24, under 510(k) number K221634.

Who is the listed applicant for Oxymag - Transport and Emergency Ventilator?

The FDA 510(k) record lists Magnamed Tecnologia Medica S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxymag - Transport and Emergency Ventilator?

The FDA product code for Oxymag - Transport and Emergency Ventilator is BTL.

Related Clinical Trials

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.

NCT07768215Miniature In-line RespiratorNOT_YET_RECRUITING

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 KgaaK202219VORTRAN 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, LLCK161420MOVES 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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