FDA 510(k) Application Details - K170982

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K170982
Device Name	Pump, Infusion, Pca
Applicant	Smiths Medical ADS, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 US Other 510(k) Applications for this Company
Contact	Breanna Fautsch Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2017
Decision Date	08/24/2017
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