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Xltek 1421039

by Embla Systems

Xltek 1421039 is a Class II device made by Embla Systems, listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00382830027151), 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 Number00382830027151 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  • Withdrawn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
Polysomnograph
Model / reference
1421039
Primary DI / UDI-DI
00382830027151
FDA product code
MNR
GMDN term
Polysomnograph
Device class
Class II
Regulation number
868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polysomnograph

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Other devices filed under Polysomnograph.

Other devices from Embla Systems

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)