Device product
Hidrex USA DVP1000
Z-1237-2017
Product summary
- Firm
- Hidrex GmbH
- Event
- Event 76362
- Status
- Terminated
- Classification
- Class III
- Quantity
- 180 units
- Official record key
device-enforcement:Z-1237-2017
Official wording
Reason: The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Code information: SN# 16-3.6190 to 16-3.6319, 17-3.6001 to 17-3.6050
Distribution pattern: Nationwide throughout the US
Derived failure modes
-
Unknown
The device was reclassified from a class III device to a class II device and there are new documentation requirements.