Horizon Se
FDA 510(k) K070254 · Mennen Medical , Ltd.
510(k) numberK070254
Submission
- Device name
- Horizon Se
- Applicant
- Mennen Medical , Ltd.
Yavne, IL - Received
- January 26, 2007
- Decision date
- April 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|
| K141441 | Menntor X7DSI · Traditional | 01/09/2015SE |
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| 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 |
| K081484 | Horizon XvuDQK · Special | 06/20/2008SE |
| 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 |
Questions and answers
When was Horizon Se cleared by the FDA?
Horizon Se (K070254) received a 510(k) decision of Substantially Equivalent on April 19, 2007, 83 days after the submission was received.
What is the product code of K070254?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.