510(k) K133033 ยท EGJ Device, Iontophoresis, Other Uses
HIDREX PSP1000
| Applicant | Hidrex GmbH, Texas City TX, US |
| Decision | Substantially Equivalent, Apr 8, 2015 |
| Received | Sep 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133033
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2017 | Hidrex GmbH Hidrex USA DP450 Terminated |
EGJ | None listed |
| Feb 22, 2017 | Hidrex GmbH Hidrex USA DVP1000 Terminated |
EGJ | None listed |
| Feb 22, 2017 | Hidrex GmbH Daavlin Aquex (DAAV1000) Terminated |
EGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.