The following data is part of a premarket notification filed by Khn Solutions, Llc with the FDA for Bactrack Select Breathalyzer, Models S30, S50, S70.
| Device ID | K083801 |
| 510k Number | K083801 |
| Device Name: | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | KHN SOLUTIONS, LLC P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm KHN SOLUTIONS, LLC P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-03-19 |
| Summary: | summary |