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 a medical device manufactured by Translational Mri, LLC. It received FDA 510(k) clearance on 2023-03-31 under approval 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. It is manufactured by Translational Mri, LLC. The 510(k) number is K211059.
When was CereFlow V1.2 approved by the FDA?
CereFlow V1.2 received FDA 510(k) clearance on 2023-03-31, under approval number K211059.
What company makes CereFlow V1.2?
CereFlow V1.2 is manufactured by Translational Mri, LLC.
What is the FDA product code for CereFlow V1.2?
The FDA product code for CereFlow V1.2 is LLZ.
Related Devices (Code: LLZ)
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.