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FDA 510(k) Application Details - K162137
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K162137
Device Name
Thermometer, Electronic, Clinical
Applicant
VivaLnk Inc.
4655 Old Ironsides Dr. #390
Santa Clara, CA 95054 US
Other 510(k) Applications for this Company
Contact
Cecilia Xi
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
08/01/2016
Decision Date
01/19/2017
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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