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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact CHERITA JAMES
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received05/13/2011
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
Predetermined Change
Control Plan Authorized		 No
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