FDA 510(k) Application Details - K170669

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K170669
Device Name	Calculator, Drug Dose
Applicant	Voluntis S.A. 58, Avenue de Wagram Paris 75017 FR Other 510(k) Applications for this Company
Contact	Raffi Krikorian 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	03/06/2017
Decision Date	06/19/2017
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