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FDA 510(k) Application Details - K190717
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K190717
Device Name
Thermometer, Electronic, Clinical
Applicant
Shenzhen Pacom Medical Instruments Co., Ltd.
8th floor of B District, B Building, No.5, Industry five
road, Jianbian Community
Shenzhen 518105 CN
Other 510(k) Applications for this Company
Contact
Xuewen Chen
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
03/20/2019
Decision Date
12/13/2019
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
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