510(k) K243143 ยท QAI Powered Microneedle Device
E-PEN (E-PEN)
| Applicant | Bomtech Electronics Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Apr 7, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243143
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.