FDA-Device2017-03-01Class III
Hidrex USA DVP1000
Hidrex GmbH
Hazard
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Sold states
Nationwide throughout the US
Affected count
180 units
Manufactured in
Otto-Hahn-Str. 12, N/A, Heiligenhaus, N/A, Germany
Products
Hidrex USA DVP1000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2017Don't want to check this manually?
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