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) (6) Ventilatory Effort Recorder (MNR) (5) Standard Polysomnograph With Electroencephalograph (OLV) (4)

Premarket Exempt

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Compumedics Grael - 09342451001245 Catalog Number : 8028-0003-01

Device Description : Grael cradle assembly

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR, GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001252 Catalog Number : 9028-0003-02

Device Description : Grael EEG v2 System - no software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001269 Catalog Number : 8028-0001-02

Device Description : Grael v2 Assembly

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : OLV, GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001276 Catalog Number : 9028-0001-02

Device Description : Grael v2 System, no software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ, OLV

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001283 Catalog Number : 8028-0008-01

Device Description : Grael LT Assembly

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR, GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001290 Catalog Number : 9028-0008-01

Device Description : Grael LT System, no software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR, GWQ

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001306 Catalog Number : 8028-0007-01

Device Description : Grael PSG Assembly

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Compumedics Grael - 09342451001313 Catalog Number : 9028-0009-01

Device Description : Grael PSG System, no software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001368 Catalog Number : 9023-0002-01

Device Description : Somte PSG v2 System, No software

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001382 Catalog Number : 8023-0001-02

Device Description : Somte PSG v2 Assembly

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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