HYDRADJUST IV UROLOGICAL TABLE— 510(k) K943581
Substantially EquivalentMallinckrodt Group, Inc.
FDA 510(k) clearance K943581 for HYDRADJUST IV UROLOGICAL TABLE, Substantially Equivalent on 1995-01-04. Applicant: Mallinckrodt Group, Inc.. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Group, Inc.
- Product code
- Code IXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code IXR
view allMore clearances from Mallinckrodt Group, Inc.
view allRecalls naming K943581
K-number listed on FDA's recall record- Z-2833-2018 — Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
- Z-1753-2013 — Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943581.
Data sourced from openFDA. This site is unofficial and independent of the FDA.