FDA-Device2023-05-10Class II
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
DeVilbiss Healthcare LLC
Hazard
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Sold states
Worldwide - US Nationwide distribution.
Affected count
143,397 units
Manufactured in
100 Devilbiss Dr, Somerset, PA, United States
Products
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2023Don't want to check this manually?
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