TECHNOS MP, MODEL AU6


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K023255
Device Name TECHNOS MP, MODEL AU6
Original Applicant
BIOSOUND ESAOTE, INC.
8000 castleway dr.
indianapolis, 
IN 
46250

Original Contact colleen hittle densmore
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received 09/30/2002
Decision Date 02/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No