Embla Systems Ltd

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) (8) Electrode, Cutaneous (GXY) (1) Full-Montage Standard Electroencephalograph (GWQ) (1)

Premarket Exempt

No

Clear

Xltek - 00382830023757 Catalog Number :

Device Description : Embletta MPR Base

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830023764 Catalog Number :

Device Description : Embletta MPR PG

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830023771 Catalog Number :

Device Description : Embletta MPR ST Proxy

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830023788 Catalog Number :

Device Description : Embletta MPR ST+ Proxy

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830023849 Catalog Number :

Device Description : Embletta MPR TX Proxy

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830023924 Catalog Number :

Device Description : Sandman Codec Software V.2.0 CD-Elite

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Xltek - 00382830024655 Catalog Number :

Device Description : Oximeter Embletta/Embla7000 XPOD

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830024662 Catalog Number :

Device Description : P32 Pulse Oxi LP Cable

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830025331 Catalog Number :

Device Description : Snap On Cable 39in/100cm Green

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Xltek - 00382830025348 Catalog Number :

Device Description : Snap On Cables 39in/100cm Orange

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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