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 - 00382830027090 Catalog Number :

Device Description : XactTrace Reusable Belt - Small Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027106 Catalog Number :

Device Description : XactTrace Reusable Belt - Medium Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027113 Catalog Number :

Device Description : XactTrace Reusable Belt - Medium Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027120 Catalog Number :

Device Description : XactTrace Reusable Belt - Large Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027137 Catalog Number :

Device Description : XactTrace Reusable Belt - Large Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027144 Catalog Number :

Device Description : XactTrace Reusable Belt-Med Thorax 78 cable length "

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027151 Catalog Number :

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

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027168 Catalog Number :

Device Description : XactTrace Reusable Belt - Small Thorax 78 cable Length "

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027175 Catalog Number :

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

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027182 Catalog Number :

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

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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