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) (10)

Premarket Exempt

Clear

Xltek - 00382830025362 Catalog Number :

Device Description : EKG Snap On Cables 78in/200cm

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830025379 Catalog Number :

Device Description : Snap On Cables 120in/300cm White

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830025386 Catalog Number :

Device Description : Snap On Cables120in/300cm Black

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830025393 Catalog Number :

Device Description : Snap Electrode Breakout Cable 40"

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Embla Systems - 00382830025928 Catalog Number :

Device Description : XactTrace Lock - Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Embla Systems - 00382830025935 Catalog Number :

Device Description : XactTrace Lock - Abdomen EBG

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830025942 Catalog Number :

Device Description : XactTrace Lock - Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830025973 Catalog Number :

Device Description : XactTrace Univ Sensor -Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830026222 Catalog Number :

Device Description : Single Use XactTrace belt - Pediatric 20/bx

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830026239 Catalog Number :

Device Description : Single Use XactTrace belt - small 20/bx

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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