System, X-ray, Mobile

Micro-X Ltd.

The following data is part of a premarket notification filed by Micro-x Ltd. with the FDA for Rover.

Pre-market Notification Details

Device IDK201488
510k NumberK201488
Device Name:Rover
ClassificationSystem, X-ray, Mobile
Applicant Micro-X Ltd. A14 6 MAB Eastern Promenade, Tonsley (clovelly Park),  AU 5042
ContactMark Norman
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2020-07-17

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