MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K081386
Device Name MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
Applicant
ESAOTE S.P.A.
11460 n. meridian st.
suite 150
carmel, 
IN 
46032

Applicant Contact allison scott
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 05/19/2008
Decision Date 09/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No