Lilium A-200E

System, Imaging, Pulsed Echo, Ultrasonic

Lilium Otsuka Co., Ltd.

The following data is part of a premarket notification filed by Lilium Otsuka Co., Ltd. with the FDA for Lilium A-200e.

Pre-market Notification Details

Device IDK170046
510k NumberK170046
Device Name:Lilium A-200E
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Lilium Otsuka Co., Ltd. 4-12-6, Chiyoda, Chuo-ku Sagamihara City,  JP 252-0237
ContactHiroaki Takahashi
CorrespondentKathryn Coressel
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-05
Decision Date2017-12-07
Summary:summary

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