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FDA 510(k) Application Details - K211752
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K211752
Device Name
Thermometer, Electronic, Clinical
Applicant
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor
No. 2 Building No. 9 Shuangyuan Road Shijingshan
Beijing 100041 CN
Other 510(k) Applications for this Company
Contact
Haiying Zhao
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
06/07/2021
Decision Date
01/21/2022
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
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