TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K030191
Device Name TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
Original Applicant
TERATECH CORP.
77-79 terrace hall ave.
burlington, 
MA 
01803

Original Contact charles f hottinger
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 01/21/2003
Decision Date 01/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No