FDA 510(k)

SomniCheck

K-Number: K223676 · 2023-06-01

Decision Date2023-06-01

Product CodeGWL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SomniCheck is the device name listed in this FDA 510(k) record. The listed applicant is Brainmatterz, LLC. It received FDA 510(k) clearance on 2023-06-01 under 510(k) 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. The listed applicant is Brainmatterz, LLC. The 510(k) number is K223676.

When did SomniCheck receive FDA 510(k) clearance?

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

Who is the listed applicant for SomniCheck?

The FDA 510(k) record lists Brainmatterz, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SomniCheck?

The FDA product code for SomniCheck is GWL.

Related Devices (Code: GWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243746Delphi AmplifierQuantalx Neroscience K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS Remware K232210X-trodes System MX-Trodes K230148VlabDormotech Medical, Ltd.

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.