BE PLUS / AURA-LTM64 AMPLIFIER— 510(k) K053606

Substantially Equivalent

Eb Neuro S.P.A.

FDA 510(k) clearance K053606 for BE PLUS / AURA-LTM64 AMPLIFIER, Substantially Equivalent on 2006-01-24. Applicant: Eb Neuro S.P.A.. Device class: 2.

Clearance details

Applicant: Eb Neuro S.P.A.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2005-12-27
Decision date: 2006-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWL

K243746 — Delphi Amplifier2025-03-12
K242832 — NExT Station; NExT Station Advanced2024-12-12
K240646 — DreamClear2024-09-04
K242305 — BE Plus PRO, Neurotravel LIGHT2024-09-04
K232210 — X-trodes System M2024-02-04

More clearances from Eb Neuro S.P.A.

K150220 — STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast2015-08-19
K142064 — GALILEO NT2015-02-13
K133517 — NEMUS 2 SYSTEM2014-02-26
K121996 — BE PLUS LTM AMPLIFIER GWI AMPLIFIER2012-08-03
K093728 — BE MICRO, TREA2010-04-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.