The following data is part of a premarket notification filed by Sentech Korea Corp. with the FDA for Breath Alcohol Test System, Model Al-6000.
| Device ID | K060343 |
| 510k Number | K060343 |
| Device Name: | BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | SENTECH KOREA CORP. 21 GRAND AVE. SUITE 103 Palisades Park, NJ 07650 |
| Contact | Matthew H Son |
| Correspondent | Matthew H Son SENTECH KOREA CORP. 21 GRAND AVE. SUITE 103 Palisades Park, NJ 07650 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-10 |
| Decision Date | 2006-05-11 |
| Summary: | summary |