ERESEARCHTECHNOLOGY, INC.

Address:1818 Market Street,Philadelphia,PA,19103,US

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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) (4)

Premarket Exempt

Yes

Clear

Opal V2C - 00850023837011 Catalog Number :

Device Description : Opal V2C is a small Worn Monitor designed for documenting physical movement asso Opal V2C is a small Worn Monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.

Device Class : 2

Duns Number: 867288557

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Docking Station V2C - 00850023837028 Catalog Number :

Device Description : Docking Station is an accessory that transfers the raw sensor data logged to a c Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.

Device Class : 2

Duns Number: 867288557

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Access Point V2C - 00850023837035 Catalog Number :

Device Description : Access Point is an accessory that enables wireless streaming to a computer for t Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.

Device Class : 2

Duns Number: 867288557

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Opal DataHub - 00850023837042 Catalog Number : ODHV2C

Device Description : The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors.

Device Class : 2

Duns Number: 867288557

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : No

Device Count : 1

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