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FDA 510(k)

Rover

K-Number: K211423 · 2021-05-21

ApplicantMicro-X Limited
Decision Date2021-05-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rover is a medical device manufactured by Micro-X Limited. It received FDA 510(k) clearance on 2021-05-21 under approval number K211423. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rover?

Rover is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by Micro-X Limited. The 510(k) number is K211423.

When was Rover approved by the FDA?

Rover received FDA 510(k) clearance on 2021-05-21, under approval number K211423.

What company makes Rover?

Rover is manufactured by Micro-X Limited.

What is the FDA product code for Rover?

The FDA product code for Rover is IZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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