Device Classification Name |
unit, neonatal phototherapy
|
510(k) Number |
K210289 |
Device Name |
Infant Phototherapy Equipment |
Applicant |
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 |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 880.5700
|
Classification Product Code |
|
Date Received | 02/02/2021 |
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
|
|
|