FDA 510(k) Application Details - K160673

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K160673
Device Name	Calculator, Drug Dose
Applicant	INSULIN ALGORITHMS 9538 W.PICO BLVD. #206 LOS ANGELES, CA 90035 US Other 510(k) Applications for this Company
Contact	Josh Davidson 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	03/10/2016
Decision Date	06/07/2017
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