DIOPSYS, INC.

DIOPSYS, INC.

Address:2 Wing Drive,Cedar Knolls,NJ,07927,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

Stimulator, Photic, Evoked Response (GWE) (10)

Premarket Exempt

No

Clear

Diopsys® - 00850514007008 Catalog Number :

Device Description : Braided ERG Lead Wire Set, Bag

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007015 Catalog Number :

Device Description : Single Channel EEG Filter/Amplifier Module

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007022 Catalog Number :

Device Description : Braided EEG Snap Lead Wire Set, Bag

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007039 Catalog Number :

Device Description : Disposable Hypoallergenic EEG Electrodes, Pouch/100

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007046 Catalog Number :

Device Description : ERG Lid Electrodes, Pouch

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007053 Catalog Number :

Device Description : ERG Lid Electrodes, Box

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007077 Catalog Number :

Device Description : NOVA Vision Testing System

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007084 Catalog Number :

Device Description : NOVA ARGOS Vision Testing System

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007091 Catalog Number :

Device Description : NOVA Software

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Diopsys® - 00850514007107 Catalog Number :

Device Description : Ganzfeld Dome

Device Class : 2

Duns Number: 009972345

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

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