LANDLEX, MODEL P100X

Vehicle, Motorized 3-wheeled

BESTEAM TECHNOLOGY INC.

The following data is part of a premarket notification filed by Besteam Technology Inc. with the FDA for Landlex, Model P100x.

Pre-market Notification Details

Device IDK060042
510k NumberK060042
Device Name:LANDLEX, MODEL P100X
ClassificationVehicle, Motorized 3-wheeled
Applicant BESTEAM TECHNOLOGY INC. 16F-2, NO.462, SEC. 2 CHONG-DE RD. Beitun District, Taichung,  TW 40653
ContactJeff Chang
CorrespondentJeff Chang
BESTEAM TECHNOLOGY INC. 16F-2, NO.462, SEC. 2 CHONG-DE RD. Beitun District, Taichung,  TW 40653
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-06
Decision Date2006-02-14
Summary:summary

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