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 a medical device manufactured by Neurovalens , Ltd.. It received FDA 510(k) clearance on 2023-10-27 under approval 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. It is manufactured by Neurovalens , Ltd.. The 510(k) number is K230826.
When was Modius Sleep approved by the FDA?
Modius Sleep received FDA 510(k) clearance on 2023-10-27, under approval number K230826.
What company makes Modius Sleep?
Modius Sleep is manufactured by Neurovalens , Ltd..
What is the FDA product code for Modius Sleep?
The FDA product code for Modius Sleep is QJQ.
Related Devices (Code: QJQ)
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.