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AccuRhythm™ AI ZA400

by Medtronic, Inc.

Ref ZA400

AccuRhythm™ AI ZA400 is a device classified as Class IIb in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0763000B00006978M), cleared under FDA 510(k) K223630 on 5 Apr 2023 (1 earlier submission) and listed in FDA GUDID since 31 Dec 2021 (UDI-DI 00763000504519), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223630

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00006978M Basic UDI-DI 00763000504519UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223630 Date5 Apr 2023DecidedStatusActive
United StatesGUDID listing GUDID Number00763000504519 UDI-DI Date31 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00006978M registered 1 Oct 2026 Active
  • FDA 510(k) K223630 decided 5 Apr 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00763000504519 listed 31 Dec 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K210484
  2. Listed FDA GUDID 00763000504519
  3. Cleared FDA 510(k) K223630
  4. Registered EUDAMED 0763000B00006978M

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  • Withdrawn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
AccuRhythm™ EUDAMED
AccuRhythm™ AI GUDID
Generic name
Implantable cardiac device management application software
Device name
AccuRhythm AI ECG Classification System
Model / reference
ZA400
Primary DI / UDI-DI
00763000504519
Basic UDI-DI
0763000B00006978M
510(k) Number
FDA product code
MXD
EMDN code
Z12050882 Cardiac telemetry instruments - software accessories
GMDN term
Implantable cardiac device management application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.1025
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
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: Implantable cardiac device management application software

Cleared under the same submission (K210484)

Cleared under the same submission (K223630)

Similar devices in this category

Other devices filed under CARDIAC TELEMETRY INSTRUMENTS.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)