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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, neonatal phototherapy
510(k) Number K210289
Device Name Infant Phototherapy Equipment
Bistos Co., Ltd.
7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302,
Galmachi-ro, Jungwon-gu
Seongnam-si,  KR 13201
Applicant Contact Dae Eun Kim
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5700
Classification Product Code
Date Received02/02/2021
Decision Date 05/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No