The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission Breath Alcohol Detector.
| Device ID | K093143 |
| 510k Number | K093143 |
| Device Name: | MISSION BREATH ALCOHOL DETECTOR |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2010-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10763924095213 | K093143 | 000 |