Medical Device Manufacturer · US , Indianpolis , IN

Eb Neuro S.P.A.

13 submissions · 13 cleared · Since 2001
13
Total
13
Cleared
0
Denied

Eb Neuro S.P.A. — FDA 510(k) Submissions

Eb Neuro S.P.A. has submitted 13 FDA 510(k) premarket notifications since 2001, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Amplifier, Physiological Signal, Ventilatory Effort Recorder, Electromyograph, Diagnostic, Standard Polysomnograph With Electroencephalograph, Non-normalizing Quantitative Electroencephalograph Software . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
NExT Station; NExT Station Advanced
K242832 · GWL Amplifier, Physiological... · Neurology
Dec 2024 84d
BE Plus PRO, Neurotravel LIGHT
K242305 · GWL Amplifier, Physiological... · Neurology
Sep 2024 30d
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
K150220 · GWF Stimulator, Electrical,... · Neurology
Aug 2015 201d
GALILEO NT
K142064 · OLT Non-normalizing... · Neurology
Feb 2015 198d
NEMUS 2 SYSTEM
K133517 · GWL Amplifier, Physiological... · Neurology
Feb 2014 103d
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K121996 · GWL Amplifier, Physiological... · Neurology
Aug 2012 25d
BE MICRO, TREA
K093728 · OLV Standard Polysomnograph... · Neurology
Apr 2010 147d
NEMUS SYSTEM; NEMUS PC PERIPHERAL
K073415 · IKN Electromyograph, Diagnostic · Neurology
May 2008 171d
SANDMAN POCKET
K061996 · MNR Ventilatory Effort Recorder · Anesthesiology
Oct 2006 81d
BE PLUS / AURA-LTM64 AMPLIFIER
K053606 · GWL Amplifier, Physiological... · Neurology
Jan 2006 28d
NIC36 AMPLIFIER
K041198 · GWL Amplifier, Physiological... · Neurology
Jun 2004 25d
SANDMAN SD20 AMPLIFIER
K040113 · GWL Amplifier, Physiological... · Neurology
Feb 2004 29d
MIZAR, BASIS BE, SANDMAN DIGITAL
K003154 · GWL Amplifier, Physiological... · Neurology
Jan 2001 87d
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