MYLABSEVEN, MYLABALPHA

Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K111302
Device Name MYLABSEVEN, MYLABALPHA
Applicant
ESAOTE, S.P.A.
11460 n meridian st., ste 150
carmel, 
IN 
46032

Applicant Contact allison scott
Correspondent
ESAOTE, S.P.A.
11460 n meridian st., ste 150
carmel, 
IN 
46032

Correspodent Contact allison scott
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 05/09/2011
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No