FDA 510(k) Application Details - K171450

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K171450
Device Name	Calculator, Drug Dose
Applicant	Glooko, Inc 899 West Evelyn Avenue Mountain View, CA 94041 US Other 510(k) Applications for this Company
Contact	Tejasvi Pasi Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	NDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2017
Decision Date	02/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review