510(k) K944983 ยท JAK System, X-Ray, Tomography, Computed
MEDRAD COUNTERPOISE SYSTEM
| Applicant | Medrad, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Nov 29, 1994 |
| Received | Oct 11, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material N Terminated |
JAK | None listed |
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 Terminated |
JAK | None listed |
| Oct 25, 2005 | Medrad Inc Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.