EzOrtho
System, Image Processing, Radiological
Ewoo Soft Co., Ltd.
The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd. with the FDA for Ezortho.
Pre-market Notification Details
| Device ID | K192888 |
| 510k Number | K192888 |
| Device Name: | EzOrtho |
| Classification | System, Image Processing, Radiological |
| Applicant | Ewoo Soft 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-10 |
| Decision Date | 2020-03-13 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019700159 | K192888 | 000 |
Trademark Results [EzOrtho]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZORTHO 79261429 not registered Live/Pending |
EWOO SOFT Co., Ltd. 2019-04-25 |
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