510(k) K110614 ยท DJZ Devices, Breath Trapping, Alcohol
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
| Applicant | Seju Engineering Co., Ltd., Yuseong-Gu, Daejeon, KR |
| Decision | Substantially Equivalent, Nov 21, 2011 |
| Received | Mar 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110614
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.