510(k) K060150 ยท IRN Device, Warning, Overload, External Limb, Powered
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
| Applicant | Andante Medical Devices , Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, Feb 23, 2006 |
| Received | Jan 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060150
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.