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FDA 510(k) Application Details - K211352
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K211352
Device Name
Thermometer, Electronic, Clinical
Applicant
Putian Hanjiang Huafeng Plastic Co., Ltd.
40M road, Jiangkou Town, Hanjiang District
Putian 351111 CN
Other 510(k) Applications for this Company
Contact
Yiqian Deng
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
05/03/2021
Decision Date
09/09/2021
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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