FDA 510(k) Application Details - K120314

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K120314
Device Name	Accessories, Pump, Infusion
Applicant	WELLDOC, INC 1501 SAINT PAUL STREET SUITE 118 BALTIMORE, MD 21202 US Other 510(k) Applications for this Company
Contact	LAUREN BRONICH-HALL 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	02/01/2012
Decision Date	02/24/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review