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Chat Fusion CF8.1

by Prentke Romich Company

Chat Fusion CF8.1 is a Class II device made by Prentke Romich Company, listed in FDA GUDID since 30 Nov 2016 (UDI-DI 00816486020018), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816486020018 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Chat Fusion
Generic name
Voice synthesizer/digitizer
Model / reference
CF8.1
Primary DI / UDI-DI
00816486020018
FDA product code
ILQ
GMDN term
Voice synthesizer/digitizer
Device class
Class II
Regulation number
890.3710
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ILQ (System, Communication, Powered).

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Properties

  • Prescription use
  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (11, all answered No)