Device Classification Name |
Thermometer, Electronic, Clinical
More FDA Info for this Device |
510(K) Number |
K210937 |
Device Name |
Thermometer, Electronic, Clinical |
Applicant |
Alicn Medical Shenzhen, Inc.
Room 410, Building A, 3rd Sub-Park, Leibo Zhongcheng Life
Sci Pk., #22 Jinxiu Rd, Jinsha Comm., Kengzi St, Pingshan
Shenzhen 518118 CN
Other 510(k) Applications for this Company
|
Contact |
Fang Meisong
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 |
03/29/2021 |
Decision Date |
05/12/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
HO - General Hospital |
Review Advisory Committee |
HO - General Hospital |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|