HIDREX PSP1000— 510(k) K133033
Substantially EquivalentHidrex GmbH
FDA 510(k) clearance K133033 for HIDREX PSP1000, Substantially Equivalent on 2015-04-08. Applicant: Hidrex GmbH. Device class: 2.
Clearance details
- Applicant
- Hidrex GmbH
- Product code
- Code EGJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5525
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Texas City, TX, US
Recent devices under product code EGJ
view allRecalls naming K133033
K-number listed on FDA's recall record- Z-1236-2017 — Hidrex USA DP450
- Z-1237-2017 — Hidrex USA DVP1000
- Z-1238-2017 — Daavlin Aquex (DAAV1000)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133033.
Data sourced from openFDA. This site is unofficial and independent of the FDA.