510(k) K052804 ยท DJZ Devices, Breath Trapping, Alcohol
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
| Applicant | Omega Point Systems, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | Oct 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052804
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.