FDA-Device2022-05-25Class II
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Caire, Inc.
Hazard
The device was not cleared for U.S. distribution.
Sold states
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Affected count
2 oxygen concentrators
Manufactured in
2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, United States
Products
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1117-2022Don't want to check this manually?
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