Aria

FDA UDI

Class II (US FDA UDI)

by Intelligent Hearing Systems Corp.

Identity

Trade Name: Aria FDA UDI
Generic Name: Evoked-potential graphic recording system FDA UDI
Model / Reference: M011160 FDA UDI

Identifiers

Primary DI / UDI-DI: 00817020021126 FDA UDI
510(k) Number: K023859 FDA UDI
K031051 FDA UDI
K061443 FDA UDI
K090579 FDA UDI
K163326 FDA UDI
K900096 FDA UDI
K964426 FDA UDI
FDA Product Code: GWJ FDA UDI
EWO FDA UDI
GMDN Term: Evoked-potential graphic recording system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1900 FDA UDI
874.1050 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

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential graphic recording system Otoacoustic emission system, line-powered Visual-reinforcement audiometer

Aria by Intelligent Hearing Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Visual-reinforcement audiometer.

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Cleared under the same submission

K023859 also covers:

K031051 also covers:

K061443 also covers:

K090579 also covers:

K163326 also covers:

Feedback Box — Intelligent Hearing Systems Corp.

K964426 also covers:

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: Intelligent Hearing Systems Corp.

Sources (1)

FDA UDI e29f3184-df98-417c-9af5-17589b66d802 33 fields · synced Jun 8, 2026