510(k) K152303 ยท IWE Monitor, Patient Position, Light-Beam
CT Sim Laser System
| Applicant | Gammex, Inc., Middleton WI, US |
| Decision | Substantially Equivalent, Sep 11, 2015 |
| Received | Aug 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152303
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.