Device Classification Name |
Transcranial Magnetic Stimulator
|
510(k) Number |
K202537 |
Device Name |
ALTMS Magnetic Stimulation Therapy System |
Applicant |
REMED Co., Ltd |
#301-#303 Migun Techno World II, 187, Techno 2-Ro |
Yuseong-gu |
Daejeon,
KR
34025
|
|
Applicant Contact |
Yonsoo Nam |
Correspondent |
K-Biotech |
201 South 4th Street, Suite 727 |
San Jose,
CA
95112
|
|
Correspondent Contact |
Kyungyoon Kang |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 09/01/2020 |
Decision Date | 11/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|