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NomoLine 4416

by Masimo Corporation

Ref 4416

NomoLine 4416 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 084399700000Z3T4D04V000LK), cleared under FDA 510(k) K171121 on 17 Nov 2017 and listed in FDA GUDID since 9 Feb 2023 (UDI-DI 00843997016902), 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) K171121

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 Number084399700000Z3T4D04V000LK Basic UDI-DI 00843997016902UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997016902 UDI-DI Date9 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171121 Date17 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z3T4D04V000LK registered 10 Aug 2026 Active
  • FDA 510(k) K171121 decided 17 Nov 2017 Active
  • FDA GUDID UDI-DI 00843997016902 listed 9 Feb 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171121
  2. Listed FDA GUDID 00843997016902
  3. Registered EUDAMED 084399700000Z3T4D04V000LK

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  • Withdrawn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
NomoLine ISA OR+ EUDAMED
NomoLine GUDID
Generic name
Respiration monitor
Model / Ref / Catalog
4416
Primary DI / UDI-DI
00843997016902
Basic UDI-DI
084399700000Z3T4D04V000LK
Direct marketing DI
00843997016902
510(k) Number
FDA product code
CCK
EMDN code
Z1203020499 Gaseous exchange monitoring instruments – other
GMDN term
Respiration monitor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.1400
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: Respiration monitor

Cleared under the same submission (K171121)

and 8 more cleared under K171121

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

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)