510(k) K093143 ยท DJZ Devices, Breath Trapping, Alcohol
MISSION BREATH ALCOHOL DETECTOR
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 28, 2010 |
| Received | Oct 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093143
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2015 | Acon Laboratories, Inc. Mission
-Breath Alcohol Detector
-15 tests
- 0.08% BAC
- Blow bags included
Product Usage:
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the Terminated |
DJZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.