Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K211795 |
Device Name |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Applicant |
Ewoosoft Co., Ltd. |
801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil |
Hwaseong-si,
KR
18449
|
|
Applicant Contact |
Young Seok Kim |
Correspondent |
Lk Consulting Group USA, Inc. |
18881 Von Karman Ave. STE 160 |
Irvine,
CA
92612
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/10/2021 |
Decision Date | 10/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|