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Natus 1421045

by Embla Systems

Natus 1421045 is a Class II device made by Embla Systems, cleared under FDA 510(k) K173793 on 1 Mar 2019 and listed in FDA GUDID since 29 Oct 2019 (UDI-DI 00382830047708), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K173793

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 Number00382830047708 UDI-DI Date29 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173793 Date1 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173793 decided 1 Mar 2019 Active
  • FDA GUDID UDI-DI 00382830047708 listed 29 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173793
  2. Listed FDA GUDID 00382830047708

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  • Withdrawn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
Polysomnograph
Model / reference
1421045
Primary DI / UDI-DI
00382830047708
510(k) Number
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.

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Properties

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