PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K110482
Device Name PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
Applicant
TERATECH CORP.
p.o. box 10074
13221 ne teem loop road
bainbridge island, 
WA 
98110

Applicant Contact charles f hottinger
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 02/18/2011
Decision Date 03/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No