ZURA TEE SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K080223
Device Name ZURA TEE SYSTEM
Applicant
IMACOR LLC
1835 market street
28th floor
philadelphia, 
PA 
19103

Applicant Contact steven b datlof m.d., j.d.
Correspondent
IMACOR LLC
1835 market street
28th floor
philadelphia, 
PA 
19103

Correspodent Contact steven b datlof m.d., j.d.
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DXK   ITX  
Date Received 01/29/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No