ISR'obot Mona Lisa 1.0

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 1.0.

Pre-market Notification Details

Device IDK203659
510k NumberK203659
Device Name:ISR'obot Mona Lisa 1.0
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Biobot Surgical Pte Ltd 2 Woodlands Spectrum L, #03-10 Woodlands Sector L Singapore,  SG 738068
ContactLim Yan Shin
CorrespondentLim Yan Shin
Biobot Surgical Pte Ltd 2 Woodlands Spectrum L, #03-10 Woodlands Sector L Singapore,  SG 738068
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-15
Decision Date2021-07-08

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