Neurotrac
FDA 510(k) K823116 · Interspec, Inc.
510(k) numberK823116
Submission
- Device name
- Neurotrac
- Applicant
- Interspec, Inc.
Mchenry, IL, US - Received
- October 21, 1982
- Decision date
- December 7, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code GWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special | Neuroelectrics Barcelona S.L.U. | 06/13/2026SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K940671 | Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound FlowmeterITX · Traditional | 11/22/1994SE |
| K924231 | Interspec Apogee ClaIYO · Traditional | 06/14/1993SE |
| K915696 | Interspec Apogee Endo-V Probe and Needle GuideITX · Traditional | 11/24/1992SE |
| K920678 | Ultrasound Imagaing System and Doppler FlowmeterITX · Traditional | 04/02/1992SE |
| K911073 | Probe Refill KitITX · Traditional | 06/06/1991SE |
| K910049 | Interspec Apogee, ModificationDPW · Traditional | 04/29/1991SE |
| K903839 | Interspec ApogeeDXK · Traditional | 11/16/1990SE |
| K900155 | Interspec 2 MHZ, Transcranial Pulsed Wave DopplerITX · Traditional | 10/05/1990SE |
| K892944 | Interspec Transesophageal Probe Model 4515JOP · Traditional | 07/19/1989SE |
| K890173 | Interspec ApogeeIYO · Traditional | 04/14/1989SE |
Questions and answers
When was Neurotrac cleared by the FDA?
Neurotrac (K823116) received a 510(k) decision of Substantially Equivalent on December 7, 1982, 47 days after the submission was received.
What is the product code of K823116?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.