FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HORIZON XVU (FFR)
K Number: K123792
·
Decision Aug 30, 2013
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
21
Review Days
263
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Basic Information
- Device Name
- HORIZON XVU (FFR)
- K Number
- K123792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mennen Medical , Ltd.
- Date Received
- December 10, 2012
- Decision Date
- August 30, 2013
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |
| K070254 | HORIZON SE | Apr 19, 2007 | Substantially Equivalent |