The following data is part of a premarket notification filed by Sentech Korea Corp. with the FDA for Breath Alcohol Test System, Model Al 2500.
Device ID | K053332 |
510k Number | K053332 |
Device Name: | BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 |
Classification | Devices, Breath Trapping, Alcohol |
Applicant | SENTECH KOREA CORP. 21 GRAND AVE. SUITE 103 Palisades Park, NJ 07650 |
Contact | Matthew Son |
Correspondent | Matthew 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 | 2005-12-01 |
Decision Date | 2006-01-20 |