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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K170046
Device Name Lilium a-200E
Applicant
Lilium Otsuka Co., Ltd.
4-12-6, Chiyoda, Chuo-Ku
Sagamihara City,  JP 252-0237
Applicant Contact Hiroaki Takahashi
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Kathryn Coressel
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received01/05/2017
Decision Date 12/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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