BrainSpec Core™ 软件
K号: K230856 · 2023-11-14
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器械摘要
BrainSpec Core™ Software is the device name listed in this FDA 510(k) record. The listed applicant is Brainspec, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K230856. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BrainSpec Core™ Software?
BrainSpec Core™ Software is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Brainspec, Inc.. The 510(k) number is K230856.
When did BrainSpec Core™ Software receive FDA 510(k) clearance?
BrainSpec Core™ Software received FDA 510(k) clearance on 2023-11-14, under 510(k) number K230856.
Who is the listed applicant for BrainSpec Core™ Software?
The FDA 510(k) record lists Brainspec, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BrainSpec Core™ Software?
The FDA product code for BrainSpec Core™ Software is LLZ.
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相关器械（代码：LLZ）
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官方来源
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