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O3 4431

by Masimo Corporation

Ref 4431

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z4T4B10V000KF Basic UDI-DI 00843997013468UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997013468 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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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 Regional Oximeter EUDAMED
O3 GUDID
Generic name
Cerebral oximeter
Model / reference
4431
Primary DI / UDI-DI
00843997013468
Basic UDI-DI
084399700000Z4T4B10V000KF
Direct marketing DI
00843997013468
FDA product code
MUD
EMDN code
Z1203020406 Cerebral oximeters
GMDN term
Cerebral oximeter
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

Related devices

Category: Cerebral oximeter

Cleared under the same submission (K182429)

Similar devices

Also classified as Cerebral oximeter.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date

Other properties (22)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No