FDA.reportPublic FDA data

510(k) K230148

Device
Vlab
Applicant
Dormotech Medical, Ltd.
510(k) number
K230148
Product code
GWL
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-11
Date received
2023-01-19
Regulation
882.1835
Classification name
Amplifier, Physiological Signal
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Abed Nassir
Address
Yitzhak Rabin 21 Afula IL 33704 33704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243746Delphi AmplifierQuantalx Neroscience2025-03-12
K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.2024-12-12
K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.2024-09-04
K240646DreamClearSomnomed Technologies Inc., Doing Business AS Remware2024-09-04
K232210X-trodes System MX-Trodes2024-02-04
K223676SomniCheckBrainmatterz, LLC2023-06-01
K220631NomadAir PMU810Neurotronics, Inc.2022-07-15
K203331Quick-20mCgx, LLC2021-05-20
K202174Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems2021-02-10
K2017478-CH Electroencephalography AmplifierHipposcreen Neurotech Corp.2020-12-27
K172312eego amplifiersEemagine Medical Imaging Solutions GmbH2018-03-30
K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.2017-10-06
K171669g.Nautilus PROG.Tec Medical Engineering GmbH2017-07-05
K151600R-40 EEG AmplifierLifelines , Ltd.2015-10-23
K133517NEMUS 2 SYSTEMEb Neuro S.P.A.2014-02-26