510(k) K053332 ยท DJZ Devices, Breath Trapping, Alcohol
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
| Applicant | Sentech Korea Corp., Palisades Park NJ, US |
| Decision | Substantially Equivalent, Jan 20, 2006 |
| Received | Dec 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053332
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.