FDA-Device2017-03-01Class III

Daavlin Aquex (DAAV1000)

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
250 units
Manufactured in
Otto-Hahn-Str. 12, N/A, Heiligenhaus, N/A, Germany
Products
Daavlin Aquex (DAAV1000)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1238-2017

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