FDA 510(k) Application Details - K002067

Device Classification Name	Computer, Blood-Pressure   More FDA Info for this Device
510(K) Number	K002067
Device Name	Computer, Blood-Pressure
Applicant	RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 UPPSALA S-754 50 SE Other 510(k) Applications for this Company
Contact	MATS GRANLUND 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	07/07/2000
Decision Date	01/11/2001
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