The following data is part of a premarket notification filed by Besteam Technology Inc. with the FDA for Landlex, Model S403x.
Device ID | K063196 |
510k Number | K063196 |
Device Name: | LANDLEX, MODEL S403X |
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 | 2006-10-20 |
Decision Date | 2007-01-23 |
Summary: | summary |