The following data is part of a premarket notification filed by Lifeloc Technologies, Inc. with the FDA for Lifeguard Backtrack B90 Breath Alcohol Tester.
| Device ID | K090766 |
| 510k Number | K090766 |
| Device Name: | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | LIFELOC TECHNOLOGIES, INC. 12441 W. 49TH AVE. SUITE 4 Wheat Ridge, CO 80033 |
| Contact | Mark Lary |
| Correspondent | Mark Lary LIFELOC TECHNOLOGIES, INC. 12441 W. 49TH AVE. SUITE 4 Wheat Ridge, CO 80033 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-07-23 |
| Summary: | summary |