ISR’obot Mona Lisa 2.0

System, Imaging, Pulsed Echo, Ultrasonic

Biobot Surgical Pte Ltd

The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isr’obot Mona Lisa 2.0.

Pre-market Notification Details

Device IDK213411
510k NumberK213411
Device Name:ISR’obot Mona Lisa 2.0
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Biobot Surgical Pte Ltd 79 Ayer Rajah Crescent, #04-05 Singapore,  SG 139955
ContactLim Yan Shin
CorrespondentLim Yan Shin
Biobot Surgical Pte Ltd 79 Ayer Rajah Crescent, #04-05 Singapore,  SG 139955
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeLLZ
Subsequent Product CodeOIJ
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-19
Decision Date2021-12-22

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