ISROBOT MONA LISA


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K111347
Device Name ISROBOT MONA LISA
Applicant
BIOBOT SURGICAL PTE LTD
901 king st
suite 200
alexandria, 
VA 
22314

Applicant Contact cherita james
Correspondent
BIOBOT SURGICAL PTE LTD
901 king st
suite 200
alexandria, 
VA 
22314

Correspodent Contact cherita james
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 05/13/2011
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No