Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K160358 |
Device Name |
DT-100 |
Applicant |
Mediana Co., Ltd. |
132, Donghwagongdan-ro, Munmak-eup |
Wonju-si,
KR
220-801
|
|
Applicant Contact |
Min-hye Kim |
Correspondent |
International Regulatory Consultants |
2550 Duportail Street M275 |
Richland,
WA
99352
|
|
Correspondent Contact |
Charlie Mack |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 02/09/2016 |
Decision Date | 02/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|