Rover

System, X-ray, Mobile

Micro-X Limited

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

Pre-market Notification Details

• Device ID: K211423
• 510k Number: K211423
• Device Name: Rover
• Classification: System, X-ray, Mobile
• Applicant: Micro-X Limited A14 6 Tonsley Boulevard Cloverly Park, AU 5042
• Contact: Derek Rogers
• Correspondent: Daniel Kamm; Kamm & Associates 8870 Ravello Ct Naples, FL 34114
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-07
• Decision Date: 2021-05-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09357123000013	K211423	000
09357123000051	K211423	000
09357123000044	K211423	000
09357123000037	K211423	000