FDA 510(k)

BIT-Motion

K-Number: K211039 · 2021-12-15

Decision Date2021-12-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIT-Motion is the device name listed in this FDA 510(k) record. The listed applicant is Dde Mri Solutions, Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) 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. The listed applicant is Dde Mri Solutions, Ltd.. The 510(k) number is K211039.

When did BIT-Motion receive FDA 510(k) clearance?

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

Who is the listed applicant for BIT-Motion?

The FDA 510(k) record lists Dde Mri Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIT-Motion?

The FDA product code for BIT-Motion is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.