USBLite Solo

FDA UDI

Class II (US FDA UDI)

by Intelligent Hearing Systems Corp.

Identity

Trade Name: USBLite Solo FDA UDI
Generic Name: Evoked-potential graphic recording system FDA UDI
Model / Reference: M011140 FDA UDI

Identifiers

Primary DI / UDI-DI: 00817020020136 FDA UDI
510(k) Number: K061443 FDA UDI
FDA Product Code: GWJ FDA UDI
GWL FDA UDI
GMDN Term: Evoked-potential graphic recording system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1900 FDA UDI
882.1835 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

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

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Cleared under the same submission

K061443 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 bec45808-84f6-4234-beed-458bf2f9dd50 33 fields · synced Jun 8, 2026