VENTRI 1.1


Device Classification Name

system, tomography, computed, emission

510(k) Number K080124
Device Name VENTRI 1.1
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 hayozma st.
tirat hacarmel, 

IL

30200

Applicant Contact laurence bigio
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 01/17/2008
Decision Date 01/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls