ElectroTek— 510(k) K170441
Substantially EquivalentMobilemedtek
FDA 510(k) clearance K170441 for ElectroTek, Substantially Equivalent on 2017-06-05. Applicant: Mobilemedtek. Device class: 2.
Clearance details
- Applicant
- Mobilemedtek
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, KY, US
Recent devices under product code GWQ
view allRecalls naming K170441
K-number listed on FDA's recall record- Z-0722-2020 — 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 patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
- Z-0723-2020 — 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 a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170441.
Data sourced from openFDA. This site is unofficial and independent of the FDA.