FDA 510(k) Application Details - K172242

Device Classification Name	Monitor, Electric For Gravity Flow Infusion Systems   More FDA Info for this Device
510(K) Number	K172242
Device Name	Monitor, Electric For Gravity Flow Infusion Systems
Applicant	Shift Labs, Inc. 1600 Dexter Ave N, Suite A Seattle, WA 98109 US Other 510(k) Applications for this Company
Contact	Beth Kolko Other 510(k) Applications for this Contact
Regulation Number	880.2420   More FDA Info for this Regulation Number
Classification Product Code	FLN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2017
Decision Date	05/25/2018
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