TERASON T3200 ULTRASOUND SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K110020
Device Name TERASON T3200 ULTRASOUND SYSTEM
Applicant
TERATECH CORP.
77-79 terrace hall ave.
burlington, 
MA 
01803

Applicant Contact charles f hottinger
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received 01/03/2011
Decision Date 01/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No