Horizon Xvu
FDA 510(k) K081484 · Mennen Medical , Ltd.
510(k) numberK081484
Submission
- Device name
- Horizon Xvu
- Applicant
- Mennen Medical , Ltd.
Rohovot, IL - Received
- May 28, 2008
- Decision date
- June 20, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141441 | Menntor X7DSI · Traditional | 01/09/2015SE |
| K131789 | Cerebralogik- AeegOMA · Traditional | 12/27/2013SE |
| K123792 | Horizon Xvu (FFR)DQX · Traditional | 08/30/2013SE |
| K093766 | Vitalogik 6000/6500DSI · Special | 05/07/2010SE |
| K091165 | Horizon XvuDQK · Traditional | 08/07/2009SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | 12/16/2008SE |
| K073140 | Vitalogik Model 4000/4500DSI · Special | 11/21/2007SE |
| K071899 | Bis Module for Envoy Patient MonitorOLW · Traditional | 10/22/2007SE |
| K071348 | Ems-Xl Cardiac Electrophysiology SystemDQK · Traditional | 09/07/2007SE |
| K070254 | Horizon SeDQK · Traditional | 04/19/2007SE |
Questions and answers
When was Horizon Xvu cleared by the FDA?
Horizon Xvu (K081484) received a 510(k) decision of Substantially Equivalent on June 20, 2008, 23 days after the submission was received.
What is the product code of K081484?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.