510(k) K170441 ยท GWQ Full-Montage Standard Electroencephalograph
ElectroTek
| Applicant | Mobilemedtek, Louisville KY, US |
| Decision | Substantially Equivalent, Jun 5, 2017 |
| Received | Feb 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2019 | LIFELINES NEURO COMPANY ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a pa Terminated |
GWQ | None listed |
| Oct 11, 2019 | LIFELINES NEURO COMPANY ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of Terminated |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.