The following data is part of a premarket notification filed by Ewoosoft Co., Ltd. with the FDA for Ez3d-i/e3.
Device ID | K190791 |
510k Number | K190791 |
Device Name: | Ez3D-i/E3 |
Classification | System, Image Processing, Radiological |
Applicant | EwooSoft Co., Ltd. 801-ho, Vatechnetworks Bldg. 13, Samsung 1-ro 2-gil Hwaseong-si, KR 18449 |
Contact | Young Seok Kim |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-27 |
Decision Date | 2019-04-19 |