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FDA 510(k) Application Details - K152508
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K152508
Device Name
Thermometer, Electronic, Clinical
Applicant
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
3/F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA,
NO.33 SHENBEI ROAD
DONGGUAN 523560 CN
Other 510(k) Applications for this Company
Contact
VICTOR WAN
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
09/02/2015
Decision Date
12/31/2015
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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