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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 K213411
Device Name iSR’obot Mona Lisa 2.0
Applicant
Biobot Surgical Pte Ltd
79 Ayer Rajah Crescent, #04-05
Singapore,  SG 139955
Applicant Contact Lim Yan Shin
Correspondent
Biobot Surgical Pte Ltd
79 Ayer Rajah Crescent, #04-05
Singapore,  SG 139955
Correspondent Contact Lim Yan Shin
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   LLZ   OIJ  
Date Received10/19/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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