Device Classification Name |
Thermometer, Electronic, Clinical
More FDA Info for this Device |
510(K) Number |
K193253 |
Device Name |
Thermometer, Electronic, Clinical |
Applicant |
Shenzhen Changkun Technology Co., Ltd.
801, 3F, B building, NO. 69, zhenbi Road
Biling Community, Pingshan District
Shenzhen 518118 CN
Other 510(k) Applications for this Company
|
Contact |
Steve Li
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 |
11/18/2019 |
Decision Date |
06/17/2020 |
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 |
|