BrainSpec Core Software
K-Number: K230856 · 2023-11-14
ApplicantBrainspec, Inc.
Decision Date2023-11-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BrainSpec Core Software is a medical device manufactured by Brainspec, Inc.. It received FDA 510(k) clearance on 2023-11-14 under approval number K230856. 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 BrainSpec Core Software?
BrainSpec Core Software is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Brainspec, Inc.. The 510(k) number is K230856.
When was BrainSpec Core Software approved by the FDA?
BrainSpec Core Software received FDA 510(k) clearance on 2023-11-14, under approval number K230856.
What company makes BrainSpec Core Software?
BrainSpec Core Software is manufactured by Brainspec, Inc..
What is the FDA product code for BrainSpec Core Software?
The FDA product code for BrainSpec Core Software 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.