Class Class II
Oxymag – Transport and Emergency Ventilator (K221634)
Description
Oxymag - Transport and Emergency Ventilator by Magnamed Tecnologia Medica S/A, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221634
Clearance Date2023-05-24
Clearance TypeTraditional
Product CodeBTL
Regulation Number868.5925
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221634
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Oxymag – Transport and Emergency Ventilator (K221634) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | 2015 |
Trace the full predicate network for K221634
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.