Device Classification Name |
Thermometer, Electronic, Clinical
More FDA Info for this Device |
510(K) Number |
K162509 |
Device Name |
Thermometer, Electronic, Clinical |
Applicant |
EASYWELL BIOMEDICALS, INC.
SUITE 2, 2F, NO.9, JHANYE 1ST RD, HSINCHU SCIENCE PARK ,
Hsinchu 30078 TW
Other 510(k) Applications for this Company
|
Contact |
Arthur Chen
Other 510(k) Applications for this Contact |
Regulation Number |
880.2910
More FDA Info for this Regulation Number |
Classification Product Code |
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/08/2016 |
Decision Date |
03/10/2017 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
HO - General Hospital |
Review Advisory Committee |
HO - General Hospital |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|