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) (4)

Premarket Exempt

Clear

Compumedics - 09342451001467 Catalog Number : 7000-0270-00

Device Description : Adult silicone soft tip finger probe-oximeter-1m

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001474 Catalog Number : 7023-0003-02

Device Description : Somte PSG v2 lead kit

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001481 Catalog Number : 7023-0005-01

Device Description : SomtePSG ABDO cable (Blue)

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics Somte - 09342451001498 Catalog Number : 7023-0006-01

Device Description : SomtePSG THOR cable (Yellow)

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001504 Catalog Number : 9021-0002-01

Device Description : Package, System Unit - SynAmps RT + IMECSU-2

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001511 Catalog Number : 00081300

Device Description : Cable Assy - Deblock/MR Interface - SynAmps2

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001528 Catalog Number : 8021-0004-01

Device Description : SynAmps RT system module + IMECSU-2

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001535 Catalog Number : 9032-0003-01

Device Description : Package, Power Unit - SynAmps RT

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001542 Catalog Number : 8032-0003-01

Device Description : Assembly, SynAmps RT Power Unit

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Compumedics SynAmps RT - 09342451001559 Catalog Number : 9032-0001-01

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

Device Class : 2

Duns Number: 753750967

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

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