CNS Envision

FDA UDI

Class II (US FDA UDI)

by Moberg Research, Inc.

Identity

Trade Name: CNS Envision FDA UDI
Generic Name: Bioelectrical signal analysis software FDA UDI
Device Name: Software for use in the review, annotation and analysis of patient data collected using external physiological monitors. FDA UDI
Model / Reference: VIS-100 FDA UDI
Description: Software for use in the review, annotation and analysis of patient data collected using external physiological monitors. FDA UDI

Identifiers

Primary DI / UDI-DI: B485VIS100 FDA UDI
510(k) Number: K192572 FDA UDI
FDA Product Code: OLT FDA UDI
OMA FDA UDI
ORT FDA UDI
GMDN Term: Bioelectrical signal analysis software 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bioelectrical signal analysis software

CNS Envision by Moberg Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192572 also covers:

CNS Envision — Natus Neurology Incorporated

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Moberg Research, Inc.

Sources (1)

FDA UDI 709801aa-d45e-43ff-ba15-8f3da4b6ca4f 34 fields · synced May 30, 2026