The following data is part of a premarket notification filed by Alcotest Quebec with the FDA for Alco Tube Plus.
| Device ID | K082080 |
| 510k Number | K082080 |
| Device Name: | ALCO TUBE PLUS |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | ALCOTEST QUEBEC 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith ALCOTEST QUEBEC 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2009-04-01 |
| Summary: | summary |