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Speech Vitals - Cognition SVCOG

by Aural Analytics, Inc.

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009693401 UDI-DI Date15 Dec 2022ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Speech Vitals - Cognition
Generic Name
Cognitive assessment software
Model / Reference
SVCOG
Primary DI / UDI-DI
00860009693401
FDA Product Code
PTY
GMDN Term
Cognitive assessment software
Device Class
Class II
Regulation Number
882.1470
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No