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510(k) K221634

Oxymag - Transport and Emergency Ventilator by Magnamed Tecnologia Medica S/A — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2023
Date Received
June 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

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