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Xltek 1249014

by Embla Systems

Xltek 1249014 is a Class II device made by Embla Systems, listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00382830043489), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382830043489 UDI-DI Date25 Oct 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  • Withdrawn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
Xltek
Generic name
Sleep disorder interpretive software
Model / reference
1249014
Primary DI / UDI-DI
00382830043489
FDA product code
OLV
GMDN term
Sleep disorder interpretive software
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sleep disorder interpretive software

Similar devices

Other devices filed under FDA product code OLV (Standard Polysomnograph With Electroencephalograph).

Other devices from Embla Systems

See all devices from Embla Systems →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)