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FDA 510(k) Application Details - K162532
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K162532
Device Name
Accessories, Pump, Infusion
Applicant
WELLDOC, INC
10221 WINCOPIN CIRCLE SUITE 150
COLUMBIA, MD 21044 US
Other 510(k) Applications for this Company
Contact
DANIELLE DORFMAN
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2016
Decision Date
01/12/2017
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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