FDA.reportPublic FDA data

COMPUMEDICS USA, INC.

Matched from indexed company URL: COMPUMEDICS LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16509463002716534COMPUMEDICS USA, INC.1Y2026-01-015015 West WT Harris Blvd, Suite E Charlotte NC US 28269

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09342451002433Compumedics Curry - CURRY 9+61384207386support@compumedics.com.au
09342451002433Compumedics Curry - CURRY 91-877-294-1346support@compumedicsusa.com
09342451002655Compumedics Somfit - Somfit Main Unit+61384207386support@compumedics.com.au
09342451002655Compumedics Somfit - Somfit Main Unit1-877-294-1346support@compumedicsusa.com
09342451002662Compumedics Somfit - Somfit Charger+61384207386support@compumedics.com.au
09342451002662Compumedics Somfit - Somfit Charger1-877-294-1346support@compumedicsusa.com
09342451002747Compumedics Falcon - Falcon HST Main Unit+61384207386support@compumedics.com.au

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
532381440247498K252383Somfit DMNR2025-08-28
532381112724580K242447Falcon HSTOLV2025-02-20
532381796842541K230073OktiGWQ2023-02-09
532381556078342K191785Orion LifeSpan MEGOLY2020-02-14
532381443146615K093223COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECGGWQ2010-01-15
532381900356533K081151COMPUMEDICS NEUVOGWQ2008-09-08
532381003355054K072201COMPUMEDICS SOMTE PSG RECORDING SYSTEMMNR2008-04-14
532381206258507K033052CONDUCTIVE EEG ELECTROLYTEGYB2003-12-17
532381775725097K023771SYNAMPS2GWQ2003-02-06
532381522199485K023536NUAMPSOLT2003-01-15
532381283939250K021176COMPUMEDICS SOMTE SYSTEMMNR2003-01-21
532381064881611K011241NEUROSOFT'S SOURCEOLX2001-09-19
532381026838614K003175COMPUMEDICS SIESTA SYSTEMOLV2000-12-27
532381994762862K001781CURRY MULTIMODAL NEUROIMAGING SOFTWAREOLX2001-02-05
532381195757266K001564SCAN LT40 (40 CHANNELS)OLT2000-11-24
532381496003712K001562NEURO SCAN MEDICAL SYSTEMS A4000IKN2000-08-16
532381347976812K001324SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)OLT2000-07-11
532381679566855K000865QUIK-CAPGXY2000-04-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWQ62023-02-09
OLX42001-09-19
MNR32025-08-28
OLT32003-01-15
OLV22025-02-20
GYB22003-12-17
GXY22000-04-18
OLY12020-02-14
IKN12000-08-16

PMN#

Somfit

2023-11-30

Compumedics Limited

Okti

2023-02-09

Compumedics Limited

GUDID#

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