FDA 510(k) Application Details - K163099

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K163099
Device Name	Calculator, Drug Dose
Applicant	Sanofi, Inc. 640 Memorial Drive Cambridge, MA 02139 US Other 510(k) Applications for this Company
Contact	Robert Ezzell 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	11/07/2016
Decision Date	03/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review