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Esprit Nova

FDA UDI

Class II (US FDA UDI)

by Signalitica Inc

Identity

Trade Name
Esprit Nova FDA UDI
Generic Name
Sleep disorder interpretive software, professional-only FDA UDI
Device Name
Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep. FDA UDI
Model / Reference
v 1.1 FDA UDI
Description
Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep. FDA UDI

Identifiers

Primary DI / UDI-DI
00627987257502 FDA UDI
510(k) Number
K182227 FDA UDI
FDA Product Code
OLZ FDA UDI
GMDN Term
Sleep disorder interpretive software, professional-only FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Sleep disorder interpretive software, professional-only

Esprit Nova by Signalitica Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sleep disorder interpretive software, professional-only.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Signalitica Inc

Sources (1)

  • FDA UDI 708af24f-20ca-493a-937c-38d1f4b70992 34 fields · synced Jun 1, 2026