510(k) K122410 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
I RUNE (I-200L)
| Applicant | Medirune Co, Ltd., Gangnam-Gu, KR |
| Decision | Substantially Equivalent, Nov 12, 2013 |
| Received | Aug 8, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122410
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.