The following data is part of a premarket notification filed by Q3 Innovations, Llc with the FDA for Alcohawk Model Pt500 Digital Alcohol Detector.
| Device ID | K080848 |
| 510k Number | K080848 |
| Device Name: | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | Q3 INNOVATIONS, LLC P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm Q3 INNOVATIONS, 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 | 2008-03-26 |
| Decision Date | 2008-07-25 |
| Summary: | summary |