Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BE Plus PRO, Neurotravel LIGHT

K-Number: K242305 · 2024-09-04

ApplicantEb Neuro S.P.A.
Decision Date2024-09-04
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BE Plus PRO, Neurotravel LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Eb Neuro S.P.A.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K242305. 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 BE Plus PRO, Neurotravel LIGHT?

BE Plus PRO, Neurotravel LIGHT is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Eb Neuro S.P.A.. The 510(k) number is K242305.

When did BE Plus PRO, Neurotravel LIGHT receive FDA 510(k) clearance?

BE Plus PRO, Neurotravel LIGHT received FDA 510(k) clearance on 2024-09-04, under 510(k) number K242305.

Who is the listed applicant for BE Plus PRO, Neurotravel LIGHT?

The FDA 510(k) record lists Eb Neuro S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BE Plus PRO, Neurotravel LIGHT?

The FDA product code for BE Plus PRO, Neurotravel LIGHT is GWL.

Other records listing Eb Neuro S.P.A. 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.

K242832NExT Station; NExT Station Advanced

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 NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.K223676SomniCheckBrainmatterz, LLC

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.

↑