ISR'obot Biopsy Kit

Transducer, Ultrasonic, Diagnostic

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 Biopsy Kit.

Pre-market Notification Details

Device IDK163502
510k NumberK163502
Device Name:ISR'obot Biopsy Kit
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant Biobot Surgical Pte Ltd 79, Ayer Rajah Crescent, #04-05/06 Singapore,  SG 139955
ContactLai Chee Liew
CorrespondentLai Chee Liew
Biobot Surgical Pte Ltd 79, Ayer Rajah Crescent, #04-05/06 Singapore,  SG 139955
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-14
Decision Date2017-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08885014610023 K163502 000

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