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FDA 510(k)

Modius Sleep

K-Number: K230826 · 2023-10-27

ApplicantNeurovalens , Ltd.
Decision Date2023-10-27
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Modius Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Neurovalens , Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K230826. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modius Sleep?

Modius Sleep is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Neurovalens , Ltd.. The 510(k) number is K230826.

When did Modius Sleep receive FDA 510(k) clearance?

Modius Sleep received FDA 510(k) clearance on 2023-10-27, under 510(k) number K230826.

Who is the listed applicant for Modius Sleep?

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

What is the FDA product code for Modius Sleep?

The FDA product code for Modius Sleep is QJQ.

Related Clinical Trials

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Other records listing Neurovalens , Ltd. as applicant

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.

K232253Modius Stress

Related Devices (Code: QJQ)

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.

K252951Genesis SleepNeurofield, Inc.K232253Modius StressNeurovalens LimitedK182311CervellaInnovative Neurological Devices, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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