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FDA 510(k)

SomniCheck

K-Number: K223676 · 2023-06-01

ApplicantBrainmatterz, LLC
Decision Date2023-06-01
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SomniCheck is a medical device manufactured by Brainmatterz, LLC. It received FDA 510(k) clearance on 2023-06-01 under approval number K223676. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SomniCheck?

SomniCheck is a medical device that received FDA 510(k) clearance on 2023-06-01. It is manufactured by Brainmatterz, LLC. The 510(k) number is K223676.

When was SomniCheck approved by the FDA?

SomniCheck received FDA 510(k) clearance on 2023-06-01, under approval number K223676.

What company makes SomniCheck?

SomniCheck is manufactured by Brainmatterz, LLC.

What is the FDA product code for SomniCheck?

The FDA product code for SomniCheck is GWL.

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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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