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FDA 510(k)

AccuBrain

K-Number: K202847 · 2021-01-15

ApplicantBrainnow Medical Technology Limited
Decision Date2021-01-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuBrain is a medical device manufactured by Brainnow Medical Technology Limited. It received FDA 510(k) clearance on 2021-01-15 under approval number K202847. 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 AccuBrain?

AccuBrain is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Brainnow Medical Technology Limited. The 510(k) number is K202847.

When was AccuBrain approved by the FDA?

AccuBrain received FDA 510(k) clearance on 2021-01-15, under approval number K202847.

What company makes AccuBrain?

AccuBrain is manufactured by Brainnow Medical Technology Limited.

What is the FDA product code for AccuBrain?

The FDA product code for AccuBrain is LLZ.

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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.

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