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Outside the U.S.
Profusa received CE Mark to market the Lumee™ Oxygen Platform.
Caution: Investigational Device limited by federal (or United States) law to Investigational Use.
In the European Union, the Lumee™ Oxygen Platform is CE Marked. In the United States, the Lumee Oxygen Platform is an Investigational Device Limited by Federal Law to Investigational Use.
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