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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number882.5805
Classification Product Code
OBP  
Date Received09/01/2020
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
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