Genesis Sleep
K-Number: K252951 · 2025-12-31
ApplicantNeurofield, Inc.
Decision Date2025-12-31
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Genesis Sleep is a medical device manufactured by Neurofield, Inc.. It received FDA 510(k) clearance on 2025-12-31 under approval number K252951. 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 Genesis Sleep?
Genesis Sleep is a medical device that received FDA 510(k) clearance on 2025-12-31. It is manufactured by Neurofield, Inc.. The 510(k) number is K252951.
When was Genesis Sleep approved by the FDA?
Genesis Sleep received FDA 510(k) clearance on 2025-12-31, under approval number K252951.
What company makes Genesis Sleep?
Genesis Sleep is manufactured by Neurofield, Inc..
What is the FDA product code for Genesis Sleep?
The FDA product code for Genesis Sleep is QJQ.
Related Clinical Trials
Other Devices by Neurofield, Inc.
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.