EzOrtho
System, Image Processing, Radiological
Ewoosoft Co., Ltd
The following data is part of a premarket notification filed by Ewoosoft Co., Ltd with the FDA for Ezortho.
Pre-market Notification Details
| Device ID | K211793 |
| 510k Number | K211793 |
| Device Name: | EzOrtho |
| 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. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2021-08-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019700258 | K211793 | 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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