TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K080234
Device Name TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
Applicant
TERATECH CORP.
77-79 terrace hall ave.
burlington, 
MA 
01803

Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 01/30/2008
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No