Signalitica Inc

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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

Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (1)

Premarket Exempt

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Esprit Nova - 00627987257502 Catalog Number :

Device Description : Esprit Nova is a software application that analyzes previously recorded physiolo Esprit Nova is a software application that analyzes previously recorded physiological signals obtainedduring sleep.

Device Class : 2

Duns Number: 203746532

Premarket Exempt : No

Product Code : OLZ

Prescription Use : Yes

Device Count : 1

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