The following data is part of a premarket notification filed by Seju Engineering Co., Ltd. with the FDA for Pad (personal Alcohol Detector) Breath Alcohol Test System.
| Device ID | K110614 |
| 510k Number | K110614 |
| Device Name: | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | SEJU ENGINEERING CO., LTD. CERTIFICATION DIVISION D-524 MIGUN TECHNO WORLD2, Yuseong-gu, Daejeon, KR 305-500 |
| Contact | Eileen Yang |
| Correspondent | Eileen Yang SEJU ENGINEERING CO., LTD. CERTIFICATION DIVISION D-524 MIGUN TECHNO WORLD2, Yuseong-gu, Daejeon, KR 305-500 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-11-21 |
| Summary: | summary |