Device Classification Name |
electrocardiograph
|
510(k) Number |
K232823 |
Device Name |
MCG-S (AM1000) |
Applicant |
AMCG Co., Ltd. |
F8, 156, Seochojungang-ro, Seocho-gu |
Seoul,
KR
06605
|
|
Applicant Contact |
Soyeon Kim |
Correspondent |
AMCG Co., Ltd. |
F8, 156, Seochojungang-ro, Seocho-gu |
Seoul,
KR
06605
|
|
Correspondent Contact |
Soyeon Kim |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 09/13/2023 |
Decision Date | 04/05/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|