510(k) K935317 ยท ITI Wheelchair, Powered
ALPHA TALKER
| Applicant | Prentke Romich Co., Wooster OH, US |
| Decision | Substantially Equivalent for Some Indications, Mar 28, 1994 |
| Received | Nov 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935317
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.