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Echo Polysomnography Playback Unit ECHO320

by Neurotronics, LLC

Echo Polysomnography Playback Unit ECHO320 is a Class I device made by Neurotronics, LLC, listed in FDA GUDID since 7 Jun 2023 (UDI-DI 00817111020540), not in commercial distribution (GUDID) as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817111020540 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Echo Polysomnography Playback Unit
Generic name
Electroencephalograph tester
Model / reference
ECHO320
Primary DI / UDI-DI
00817111020540
FDA product code
GWR
GMDN term
Electroencephalograph tester
Device class
Class I
Regulation number
882.1430
GUDID distribution status
Not in Commercial Distribution

Other devices from Neurotronics, LLC

See all devices from Neurotronics, LLC →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)