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Natus 007878

by Xltek

Natus 007878 is a Class II device made by Xltek, cleared under FDA 510(k) K052112 on 28 Oct 2005 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00382830041928), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K052112

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382830041928 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK052112 Date28 Oct 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052112 decided 28 Oct 2005 Active
  • FDA GUDID UDI-DI 00382830041928 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052112
  2. Listed FDA GUDID 00382830041928

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Natus
Generic name
Electromyograph
Model / reference
007878
Primary DI / UDI-DI
00382830041928
FDA product code
IKN
GMDN term
Electromyograph
Device class
Class II
Regulation number
890.1375
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Electromyograph

Similar devices

Other devices filed under FDA product code IKN (Electromyograph, Diagnostic).

Other devices from Xltek

See all devices from Xltek →

Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)