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Polysmith Version 9.0

by Neurotronics, LLC

Polysmith Version 9.0 is a Class II device made by Neurotronics, LLC, listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00817111020755), not in commercial distribution (GUDID) as of 21 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 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817111020755 UDI-DI Date22 Sep 2016ListedStatusListed 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  • Withdrawn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

Generic name
Sleep disorder interpretive software, professional-only
Model / reference
9.0
Primary DI / UDI-DI
00817111020755
FDA product code
OLZ, OLV, DQA, MNR, GWL
GMDN term
Sleep disorder interpretive software, professional-only
Device class
Class II
Regulation number
882.1400, 870.2700, 868.2375, 882.1835
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

Other devices from Neurotronics, LLC

See all devices from Neurotronics, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)