MYLABGOLD


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K110688
Device Name MYLABGOLD
Applicant
ESAOTE
11460 n. meridian st.,
ste. 150
carmel, 
IN 
46032

Applicant Contact allison scott
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 03/11/2011
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls