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510(k) K221634

Device
Oxymag - Transport and Emergency Ventilator
Applicant
Magnamed Tecnologia Medica S/A
510(k) number
K221634
Product code
BTL
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-24
Date received
2022-06-06
Regulation
868.5925
Classification name
Ventilator, Emergency, Powered (Resuscitator)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Toru Kinjo
Address
801/831, Rua Santa Monica Cotia BR 06715-865 06715-865

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K140707LIFEBORNE INFANT RESUSCITATORInternational Biomedical2014-05-28
K131098EMERGENCY PORTABLE VENTILATORAllied Healthcare Products, Inc.2014-04-09
K132021AHP 300, EMERGENCY PORTABLE VENTILATORAllied Healthcare Products, Inc.2014-04-02
K132759VENTRAINDolphys Medical B.V.2014-03-26
K131877SAVE II, SAVE II BASICAutomedx, Inc.2014-03-21