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Nuvo

FDA UDI

Class II (US FDA UDI)

by Rm Speech

Identity

Trade Name
Nuvo FDA UDI
Generic Name
Voice synthesizer/digitizer FDA UDI
Device Name
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system. FDA UDI
Model / Reference
RMN FDA UDI
Description
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system. FDA UDI

Identifiers

Primary DI / UDI-DI
B660RMN0 FDA UDI
FDA Product Code
ILQ FDA UDI
GMDN Term
Voice synthesizer/digitizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3710 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Voice synthesizer/digitizer

Nuvo by Rm Speech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Voice synthesizer/digitizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rm Speech

Sources (1)

  • FDA UDI cb8f15f5-a249-438f-9533-ac3e2aaa5101 34 fields · synced May 30, 2026