FDA 510(k) Application Details - K011571

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K011571
Device Name	Calculator, Drug Dose
Applicant	THE RX FILES CORP. P.O. BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	YOLANDA 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	05/21/2001
Decision Date	08/09/2001
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