Device product
Hidrex USA DP450
Z-1236-2017
Product summary
- Firm
- Hidrex GmbH
- Event
- Event 76362
- Status
- Terminated
- Classification
- Class III
- Quantity
- 64 units
- Official record key
device-enforcement:Z-1236-2017
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# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020
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.