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FDA 510(k) Application Details - K170262
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K170262
Device Name
Thermometer, Electronic, Clinical
Applicant
K-Jump Health Co., Ltd.
No. 56, Wu Kung 5th Rd., New Taipei Industrial Park
New Taipei City 24890 TW
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Contact
JM Lin
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
01/27/2017
Decision Date
09/28/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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