FDA 510(k) Application Details - K003122

Device Classification Name	Computer, Blood-Pressure   More FDA Info for this Device
510(K) Number	K003122
Device Name	Computer, Blood-Pressure
Applicant	FLORENCE MEDICAL LTD. 117 AHUZAH ST. RA'ANANNA 43373 43373 IL Other 510(k) Applications for this Company
Contact	SHOSHANA FREIDMAN, RAC Other 510(k) Applications for this Contact
Regulation Number	870.1110   More FDA Info for this Regulation Number
Classification Product Code	DSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2000
Decision Date	05/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review