Embla Systems Ltd

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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

Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (1) Electrode, Cutaneous (GXY) (1) Ventilatory Effort Recorder (MNR) (1)

Premarket Exempt

Clear

Natus - 00382830047708 Catalog Number :

Device Description : XactTrace Lock - Ambu - Thorax 80"

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Embla - 00382830048484 Catalog Number :

Device Description : RemLogic 4.0 Software (English)

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : OLZ

Prescription Use : Yes

Device Count : 1

Natus - 00382830053938 Catalog Number :

Device Description : Snap On Cables 60in/150cm Black

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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