Compumedics

FDA Filings

This page includes the latest FDA filings for Compumedics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1650946
FEI Number3002716534
NameCOMPUMEDICS USA, INC.
Owner & OperatorCompumedics
Contact Address5015 W W.T. Harris Blvd Suite E
Charlotte NC 28269 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address5015 W W T Harris Blvd Ste E
Charlotte, NC 28269 US
Establishment TypeManufacture Medical Device

Registration Number9613619
FEI Number3004674371
NameCOMPUMEDICS LIMITED
Owner & OperatorCompumedics
Contact Address30-40 Flockhart Street, Abbotsford,
Melbourne AU-VIC Victoria 3067 AU
Official Correspondent
  • William Alam
  • 061-3-84207300-x
US Agent
Importing Logistics Registration
ImporterCOMPUMEDICS USA, INC.
111312307
Address5015 W WT HARRIS BLVD STE E
Charlotte, NC 28269 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address30-40 Flockhart Street, Abbotsford,
Melbourne Victoria, 3067 AU
Establishment TypeManufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
COMPUMEDICS LIMITED [Compumedics]
Orion LifeSpan MEG2020-02-18
COMPUMEDICS LIMITED [Compumedics]
Compumedics Grael System2010-12-16
COMPUMEDICS LIMITED [Compumedics]
Compumedics Grael System2010-12-16
COMPUMEDICS LIMITED [Compumedics]
Compumedics Grael System2010-12-16
COMPUMEDICS USA, INC. [Compumedics]
Compumedics Neuvo System2010-12-16
COMPUMEDICS USA, INC. [Compumedics]
Compumedics Neuvo System2010-12-16
COMPUMEDICS USA, INC. [Compumedics]
Compumedics Neuvo System2010-12-16
COMPUMEDICS USA, INC. [Compumedics]
Compumedics Neuvo System2010-12-16
COMPUMEDICS LIMITED [Compumedics]
Compumedics Sleep Monitoring System2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics Sleep Monitoring System S-series2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics Somte PSG System2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics Summit IP2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics Somte System2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics Siesta System2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics Siesta System2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics E-series Sleep System2008-11-17
COMPUMEDICS LIMITED [Compumedics]
Compumedics E-series Sleep System2008-11-17
COMPUMEDICS USA, INC. [Compumedics]
Quik Gel, Electro-conductive Gel2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SynAmps 2/RT Electroencephalograph2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
NUAMPS2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
NUAMPS2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SOURCE EEG/MEG Software2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
CURRY multimodal EEG/MEG neuroimaging software2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SCAN LT2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SCAN LT2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SCAN system2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SCAN system2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SynAmps Electroencephalograph2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
SynAmps Electroencephalograph2008-01-24
COMPUMEDICS USA, INC. [Compumedics]
QuikCap, electrode cap2008-01-24

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