FDA 510(k) Application Details - K082512

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K082512
Device Name	Calculator, Drug Dose
Applicant	DIMENSIONAL DOSING SYSTEMS, INC. 1468 HARWELL AVE CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	EJ Smith 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	08/29/2008
Decision Date	11/07/2008
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