510(k) K242305

BE Plus PRO, Neurotravel LIGHT by Eb Neuro S.P.A. — Product Code GWL

K242305 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "BE Plus PRO, Neurotravel LIGHT". The FDA issued a decision of Substantially Equivalent on September 4, 2024. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Eb Neuro S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2024
Date Received
August 5, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type