FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HORIZON SE
K Number: K070254
·
Decision Apr 19, 2007
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
21
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HORIZON SE
- K Number
- K070254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mennen Medical , Ltd.
- Date Received
- January 26, 2007
- Decision Date
- April 19, 2007
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQK), ordered by most recent decision date.
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
FDA 510(k)
FDA Class 2
·Cardiovascular
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEUS Platform (FG0501US)
FDA 510(k)
FDA Class 2
·Cardiovascular
EnSite X EP System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACORYS MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Synchrony
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Mennen Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K141441 | MENNTOR X7 | Jan 9, 2015 | Substantially Equivalent |
| K131789 | CEREBRALOGIK- AEEG | Dec 27, 2013 | Substantially Equivalent |
| K123792 | HORIZON XVU (FFR) | Aug 30, 2013 | Substantially Equivalent |
| K093766 | VITALOGIK 6000/6500 | May 7, 2010 | Substantially Equivalent |
| K091165 | HORIZON XVU | Aug 7, 2009 | Substantially Equivalent |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Dec 16, 2008 | Substantially Equivalent |
| K081484 | HORIZON XVU | Jun 20, 2008 | Substantially Equivalent |
| K073140 | VITALOGIK MODEL 4000/4500 | Nov 21, 2007 | Substantially Equivalent |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | Oct 22, 2007 | Substantially Equivalent |
| K071348 | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM | Sep 7, 2007 | Substantially Equivalent |