QIVA


Device Classification Name

computer, diagnostic, programmable

510(k) Number K021495
Device Name QIVA
Original Applicant
PIE MEDICAL IMAGING B.V.
7992 castleway dr.
indianapolis, 
IN 
46250

Original Contact colleen densmore
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 05/09/2002
Decision Date 10/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No