FDA-Device2020-01-22Class II
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Caire, Inc.
Hazard
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Sold states
US Nationwide distribution in the states of MI, CA, CT.
Affected count
4 units
Manufactured in
2200 Airport Industrial Dr Ste 500, Ball Ground, GA, United States
Products
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0805-2020Don't want to check this manually?
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