510(k) K023161 ยท IRN Device, Warning, Overload, External Limb, Powered
SMARTSTEP SYSTEM
| Applicant | Andante Medical Device, Ltd., Ra'Ananna 43373, IL |
| Decision | Substantially Equivalent, Dec 10, 2002 |
| Received | Sep 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023161
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.