Sentinel 4 EEG Analyzer
FDA 510(k) K863193 · Axon Systems, Inc.
510(k) numberK863193
Submission
- Device name
- Sentinel 4 EEG Analyzer
- Applicant
- Axon Systems, Inc.
Deer Park, NY, US - Received
- August 19, 1986
- Decision date
- December 2, 1986
- 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
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| K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationGWF · Traditional | 12/16/2003SE |
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Questions and answers
When was Sentinel 4 EEG Analyzer cleared by the FDA?
Sentinel 4 EEG Analyzer (K863193) received a 510(k) decision of Substantially Equivalent on December 2, 1986, 105 days after the submission was received.
What is the product code of K863193?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.