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

Ventilatory Effort Recorder (MNR) (6) Standard Polysomnograph With Electroencephalograph (OLV) (3) Full-Montage Standard Electroencephalograph (GWQ) (1)

Premarket Exempt

Clear

Xltek - 00382830027199 Catalog Number :

Device Description : XactTrace Reusable Belt - Large Abdomen 78" cable length

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830027205 Catalog Number :

Device Description : XactTrace Univ Sensor- Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027229 Catalog Number :

Device Description : XactTrace Universal Belt

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027434 Catalog Number :

Device Description : Snap On Cable 30in/75cm Black

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830043441 Catalog Number :

Device Description : RemLogic 3.3.2 Installation CD ENU

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Xltek - 00382830043458 Catalog Number :

Device Description : RemLogic 3.4.1 (ENU) Software

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Xltek - 00382830043489 Catalog Number :

Device Description : Enterprise 5.2 Installation CD

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Xltek - 00382830043533 Catalog Number :

Device Description : Sandman Elite 9.3 Install CD ENU

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830047456 Catalog Number :

Device Description : Single Use Universal RIP Kit - Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830047463 Catalog Number :

Device Description : Single Use Universal RIP Kit - Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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