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FDA 510(k)

CereFlow™ V1.2

K-Number: K211059 · 2023-03-31

ApplicantTranslational Mri, LLC
Decision Date2023-03-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CereFlow™ V1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Translational Mri, LLC. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K211059. 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 CereFlow™ V1.2?

CereFlow™ V1.2 is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Translational Mri, LLC. The 510(k) number is K211059.

When did CereFlow™ V1.2 receive FDA 510(k) clearance?

CereFlow™ V1.2 received FDA 510(k) clearance on 2023-03-31, under 510(k) number K211059.

Who is the listed applicant for CereFlow™ V1.2?

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

What is the FDA product code for CereFlow™ V1.2?

The FDA product code for CereFlow™ V1.2 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.

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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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