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O3 4384

by Masimo Corporation

Ref 4384

O3 4384 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 084399700000Z4T1B10V100HT), cleared under FDA 510(k) K182429 on 7 Jun 2019 and listed in FDA GUDID since 3 Sep 2020 (UDI-DI 10843997013496), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182429

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z4T1B10V100HT Basic UDI-DI 10843997013496UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997013496 UDI-DI Date3 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182429 Date7 Jun 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z4T1B10V100HT registered 23 Sep 2026 Active
  • FDA 510(k) K182429 decided 7 Jun 2019 Active
  • FDA GUDID UDI-DI 10843997013496 listed 3 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182429
  2. Listed FDA GUDID 10843997013496
  3. Registered EUDAMED 084399700000Z4T1B10V100HT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
O3 Sensor EUDAMED
O3 GUDID
Generic name
Cerebral oximeter sensor, single-use
Device name
O3 Sensors
Model / reference
4384
Primary DI / UDI-DI
10843997013496
Basic UDI-DI
084399700000Z4T1B10V100HT
Unit of use DI
00843997013499
FDA product code
MUD
EMDN code
Z1203020406 Cerebral oximeters
GMDN term
Cerebral oximeter sensor, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cerebral oximeter sensor, single-use

Cleared under the same submission (K182429)

Similar devices

Also classified as Cerebral oximeter sensor, single-use.

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)