ACTIGRAPH L.L.C.

Address:49 E Chase St,Pensacola,FL,32502,US

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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

Exerciser, Measuring (ISD) (2) Device, Sleep Assessment (LEL) (1) Medical Device Data System (OUG) (1)

Premarket Exempt

No Yes

Clear

Actigraph - 00853048008008 Catalog Number :

Device Description : The wGT3X-BT is a body worn device that measures and records physical movement a

Device Class : 2

Duns Number: 144830952

Premarket Exempt : No

Product Code : ISD

Prescription Use : Yes

Device Count : 1

ActiGraph - 00853048008015 Catalog Number :

Device Description : The GT9X is a body worn device that measures and records physical movement assoc

Device Class : 2

Duns Number: 144830952

Premarket Exempt : No

Product Code : ISD

Prescription Use : Yes

Device Count : 1

ActiGraph - 00853048008022 Catalog Number :

Device Description : The CentrePoint Data Hub is a home-based communication gateway that securely tra

Device Class : 1

Duns Number: 144830952

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

ActiGraph - 00853048008039 Catalog Number : CPW01

Device Description : The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable

Device Class : 2

Duns Number: 144830952

Premarket Exempt : No

Product Code : LEL

Prescription Use : Yes

Device Count : 1

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