Cadwell Easy Ambulatory EEG
FDA 510(k) K946094 · Cadwell Laboratories, Inc.
510(k) numberK946094
Submission
- Device name
- Cadwell Easy Ambulatory EEG
- Applicant
- Cadwell Laboratories, Inc.
Kennewick, WA, US - Received
- December 14, 1994
- Decision date
- September 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K042350 | TES-1 Constant Voltage Electrical StimulatorGWF · Traditional | 11/03/2004SE |
| K040986 | Cadwell Limb Movement ModuleLEL · Traditional | 07/01/2004SE |
| K040932 | Easynet Body Position ModuleLEL · Traditional | 07/01/2004SE |
| K971214 | KilowinGWE · Traditional | 06/11/1998SE |
| K962458 | Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962457 | Two-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962455 | Four-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K933808 | EEG Cup ElectrodeGXY · Traditional | 12/29/1994SE |
Questions and answers
When was Cadwell Easy Ambulatory EEG cleared by the FDA?
Cadwell Easy Ambulatory EEG (K946094) received a 510(k) decision of Substantially Equivalent on September 12, 1995, 272 days after the submission was received.
What is the product code of K946094?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.