The following data is part of a premarket notification filed by Besteam Technology Inc. with the FDA for Landlex, Model: 402x.
| Device ID | K083303 |
| 510k Number | K083303 |
| Device Name: | LANDLEX, MODEL: 402X |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | BESTEAM TECHNOLOGY INC. 14F-2 NO. 1 LANE 25 ZHUANGJING RD. Banqiao, TW 220 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang BESTEAM TECHNOLOGY INC. 14F-2 NO. 1 LANE 25 ZHUANGJING RD. Banqiao, TW 220 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-01-26 |
| Summary: | summary |