FDA 510(k) Application Details - K141929

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K141929
Device Name	Calculator, Drug Dose
Applicant	ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	CHUNHONG(EMMA) TAO 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	07/16/2014
Decision Date	03/16/2015
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