510(k) K011160 ยท JAK System, X-Ray, Tomography, Computed
E-Z EM PERCUPUMP 2001 CT INJECTOR
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, May 16, 2001 |
| Received | Apr 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2005 | E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and Terminated |
JAK | None listed |
| Feb 16, 2005 | E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and Terminated |
JAK | None listed |
| Feb 16, 2005 | E-Z-EM, Inc Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: T Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.