FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X4 SYSTEM
K Number: K130013
·
Decision Jan 31, 2013
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
27
Applicant Total
14
Review Days
29
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
- X4 SYSTEM
- K Number
- K130013
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Brain Monitoring, Inc.
- Date Received
- January 2, 2013
- Decision Date
- January 31, 2013
- Product Code
- OMC
- 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 |
|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMC), ordered by most recent decision date.
NX01 (NX01)
FDA 510(k)
FDA Class 2
·Neurology
SignalNED System (Model RE)
FDA 510(k)
FDA Class 2
·Neurology
REMI Remote EEG Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
Natus BrainWatch System
FDA 510(k)
FDA Class 2
·Neurology
QUEX ED; QUEX S
FDA 510(k)
FDA Class 2
·Neurology
SignalNED System (Model RE)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Advanced Brain Monitoring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153412 | Sleep Profiler | Mar 14, 2016 | Substantially Equivalent |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | Oct 30, 2015 | Substantially Equivalent |
| K140190 | NIGHT SHIFT | May 29, 2014 | Substantially Equivalent |
| K131383 | X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE | Nov 27, 2013 | Substantially Equivalent |
| K130007 | SLEEP PROFILER | Apr 17, 2013 | Substantially Equivalent |
| K120450 | SLEEP PROFILER | Sep 19, 2012 | Substantially Equivalent |
| K120447 | X4 | Jun 20, 2012 | Substantially Equivalent |
| K112514 | APNEA RISK EVALUATION SYSTEM (ARES) | Jan 9, 2012 | Substantially Equivalent |
| K111110 | APNEA GUARD | Jul 22, 2011 | Substantially Equivalent |
| K111194 | APNEA RISK EVALUATION SYSTEM (ARES) | Jul 7, 2011 | Substantially Equivalent |