The following data is part of a premarket notification filed by Sentech Korea Corp. with the FDA for Breath Alcohol Test System, Model Al-5000.
| Device ID | K061922 |
| 510k Number | K061922 |
| Device Name: | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | SENTECH KOREA CORP. 1460-1 SEOYANG B/D SEOCHO-DONG, SEOCHO-KU Seoul, KR 13786 |
| Contact | Daniel Park |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-07 |
| Decision Date | 2006-10-30 |
| Summary: | summary |