X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software
FDA 510(k) K131383 · Advanced Brain Monitoring, Inc.
510(k) numberK131383
Submission
- Device name
- X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software
- Applicant
- Advanced Brain Monitoring, Inc.
Dousman, WI, US - Received
- May 14, 2013
- Decision date
- November 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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| K260455 | New Wave SystemGWQ · Special | Zeto, Inc. | 03/13/2026SE |
| K233403 | Flexset SystemGWQ · Traditional | Zeto, Inc. | 04/30/2024SE |
| K231366 | Neuronaute PlusGWQ · Traditional | Bioserenity Sas | 11/09/2023SE |
| K221959 | Q21GWQ · Traditional | Neurofield, Inc. | 08/31/2023SE |
| K231457 | SPARK ScanGWQ · Traditional | Spark Neuro, Inc. | 08/18/2023SE |
| K221963 | Cumulus Functional Neurophysiology PlatformGWQ · Traditional | Cumulus Neuroscience Limited | 04/27/2023SE |
| K230073 | OktiGWQ · Traditional | Compumedics Limited | 02/09/2023SE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special | Bioserenity | 01/12/2023SE |
| K220056 | iSyncWaveGWQ · Traditional | iMediSync, Inc. | 08/10/2022SE |
More from iMediSync, Inc.
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|---|---|---|
| K172799 | Positional Sleep Assessment System (PoSAS) softwareMNR · Traditional | 03/09/2018SE |
| K153412 | Sleep ProfilerOLZ · Traditional | 03/14/2016SE |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…OMC · Traditional | 10/30/2015SE |
| K140190 | Night ShiftMYB · Traditional | 05/29/2014SE |
| K130007 | Sleep ProfilerOLZ · Traditional | 04/17/2013SE |
| K130013 | X4 SystemOMC · Special | 01/31/2013SE |
| K120450 | Sleep ProfilerOLZ · Traditional | 09/19/2012SE |
| K120447 | X4OMC · Traditional | 06/20/2012SE |
| K112514 | Apnea Risk Evaluation System (Ares)MNR · Traditional | 01/09/2012SE |
| K111110 | Apnea GuardLRK · Traditional | 07/22/2011SE |
Questions and answers
When was X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software cleared by the FDA?
X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (K131383) received a 510(k) decision of Substantially Equivalent on November 27, 2013, 197 days after the submission was received.
What is the product code of K131383?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.