The following data is part of a premarket notification filed by Lilium Otsuka Co., Ltd. with the FDA for Lilium A-200e.
Device ID | K170046 |
510k Number | K170046 |
Device Name: | Lilium A-200E |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | Lilium Otsuka Co., Ltd. 4-12-6, Chiyoda, Chuo-ku Sagamihara City, JP 252-0237 |
Contact | Hiroaki Takahashi |
Correspondent | Kathryn Coressel Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-05 |
Decision Date | 2017-12-07 |
Summary: | summary |