COMPUMEDICS LIMITED

Address:30-40 Flockhart Street,,Melbourne Victoria,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Full-Montage Standard Electroencephalograph (GWQ) (5) Ventilatory Effort Recorder (MNR) (4) Standard Polysomnograph With Electroencephalograph (OLV) (1)

Premarket Exempt

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Compumedics SynAmps RT - 09342451001566 Catalog Number : 8032-0001-01

Device Description : Assembly, SynAmps RT, 64-Channel Headbox

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001573 Catalog Number : 9032-0002-01

Device Description : Package, System Unit - SynAmps RT

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001580 Catalog Number : 8032-0002-01

Device Description : Assembly, SynAmps RT System Unit

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001733 Catalog Number : 9012-0003-01

Device Description : Somte Recording System Compumedics, no Software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001740 Catalog Number : 8012-0007-02

Device Description : Assembly - Somte Recording Unit Compumedics

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001757 Catalog Number : 8012-0008-05

Device Description : Assembly, Somte PIB , Compumedics

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001764 Catalog Number : 7012-0015-01

Device Description : Somte Compumedics Sensor Kit

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001771 Catalog Number : 9028-0002-02

Device Description : Grael v2 System with PSG software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001825 Catalog Number : 9028-0004-02

Device Description : Grael EEG v2 System with EEG software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001832 Catalog Number : 9028-0010-01

Device Description : Grael LT Package EEG4

Device Class :

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

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