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FDA 510(k)

BIT-Motion

K-Number: K211039 · 2021-12-15

ApplicantDde Mri Solutions, Ltd.
Decision Date2021-12-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIT-Motion is a medical device manufactured by Dde Mri Solutions, Ltd.. It received FDA 510(k) clearance on 2021-12-15 under approval number K211039. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIT-Motion?

BIT-Motion is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Dde Mri Solutions, Ltd.. The 510(k) number is K211039.

When was BIT-Motion approved by the FDA?

BIT-Motion received FDA 510(k) clearance on 2021-12-15, under approval number K211039.

What company makes BIT-Motion?

BIT-Motion is manufactured by Dde Mri Solutions, Ltd..

What is the FDA product code for BIT-Motion?

The FDA product code for BIT-Motion is LLZ.

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Official Source

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

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