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FDA 510(k) Application Details - K240023
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K240023
Device Name
Thermometer, Electronic, Clinical
Applicant
Shenzhen Yi Fang Blister Packaging Co., Ltd.
4/F, Bldg BC, Weixinda Industrial Park, Longteng Community
Xixiang, BaoÆan District
Shenzhen 518126 CN
Other 510(k) Applications for this Company
Contact
Xu Junwen
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
01/03/2024
Decision Date
03/01/2024
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
FDA Source Information for K240023
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