FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sleep Profiler
K Number: K153412
·
Decision Mar 14, 2016
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
35
Applicant Total
14
Review Days
110
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Basic Information
- Device Name
- Sleep Profiler
- K Number
- K153412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Brain Monitoring, Inc.
- Date Received
- November 25, 2015
- Decision Date
- March 14, 2016
- Product Code
- OLZ
- 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 |
|---|---|---|---|
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Advanced Brain Monitoring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K130013 | X4 SYSTEM | Jan 31, 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 |