510(k) K061922 ยท DJZ Devices, Breath Trapping, Alcohol
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
| Applicant | Sentech Korea Corp., Seoul, KR |
| Decision | Substantially Equivalent, Oct 30, 2006 |
| Received | Jul 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061922
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.