FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
K Number: K083063
·
Decision Dec 16, 2008
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
37
Applicant Total
21
Review Days
63
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
- BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
- K Number
- K083063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mennen Medical , Ltd.
- Date Received
- October 14, 2008
- Decision Date
- December 16, 2008
- Product Code
- OLW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| OLW | Index-Generating Electroencephalograph Software | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLW), ordered by most recent decision date.
BIS Advance Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
Brain Anesthesia Response Monitor (Bar Monitor)
FDA 510(k)
FDA Class 2
·Neurology
Masimo SedLine Sedation Monitor and Accessories
FDA 510(k)
FDA Class 2
·Neurology
NeuroSENSE Monitoring System, Model NS-901
FDA 510(k)
FDA Class 2
·Neurology
SedLine Sedation Monitor
FDA 510(k)
FDA Class 2
·Neurology
Entropy Module, E-ENTROPY-01
FDA 510(k)
FDA Class 2
·Neurology
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 |
| 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 |