(111 days)
No
The summary describes a standard EEG system for acquiring, displaying, and storing brain activity. There is no mention of AI or ML being used for analysis, interpretation, or any other function. The device explicitly states it "does not draw any diagnostic conclusions."
No
The device is intended for diagnosis and monitoring (acquiring, displaying, and storing electrical activity of a patient's brain), not for treatment.
Yes
The device, ElectroTek, is intended to acquire, display, and store the electrical activity of a patient's brain (EEG) to aid in diagnosis, which is a diagnostic purpose.
No
The device description explicitly states that the ElectroTek EEG System is comprised of custom hardware, firmware, peripheral devices, cables, and disposables, in addition to software. This indicates it is a hardware-based system with accompanying software, not a software-only device.
Based on the provided information, the ElectroTek electroencephalographic system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- ElectroTek's Function: The ElectroTek system acquires, displays, and stores the electrical activity of the patient's brain by placing electrodes on the scalp. This is a measurement of physiological activity in vivo (within the living body), not an examination of a specimen in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for acquiring, displaying, and storing electrical activity of the brain to aid in diagnosis. It explicitly states it "does not draw any diagnostic conclusions." This further reinforces its role as a data acquisition and display tool, not a device that analyzes biological specimens.
Therefore, the ElectroTek falls under the category of a medical device used for physiological monitoring and recording, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 scalp.
The ElectroTek is intended to be used for such studies as electroencephelogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Product codes
GWO, GWL
Device Description
The ElectroTek is a portable EEG system designed to improve the overall EEG test experience for the patient, the electroneurodiagnostic technician running the EEG test, and the physician that reads the EEG results. The ElectroTek is optimized for fast setup with easy and intuitive use, resulting in improvements in overall usability at a lower total cost of ownership for an EEG system. The ElectroTek is designed to push data to the MobileMedTek Portal for secure archived data storage and remote viewing over the web by the reading physician. The ElectroTek's is used for routine EEG studies in outpatient clinic and small/medium hospital settings. The ElectroTek is also designed to be used in long term monitoring (LTM) conditions exceeding 24 hours per study.
The ElectroTek EEG System is comprised of the case, device, custom hardware, the computing device, control software, firmware, peripheral devices, cables, and disposables. The peripheral devices include a Photic Stimulator for inducing seizure activity and a manually activated pushbutton Event Marker. Three primary Cables supplied by MobileMedTek as part of the ElectroTek include a Peripheral Cable that connects the Photic Stimulator to the ElectroTek Custom Hardware, the Event Marker cable that includes the handheld pushbutton and connects to the ElectroTek Custom Hardware, and a Patient Cable that includes a plug-in "yoke" box and connects to the ElectroTek Custom Hardware. Consumable Cables that will be supplied by MobileMedTek include four different electrode cables (the Sagittal (aka, "Midline") cable, the Parasagittal cable, the Transverse cable, and Individual cables. These cables are intended for re-use. The only single-use Disposables planned for the ElectroTek are the electrode cups that snap into the four consumable Cables and connect to the patient's head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
outpatient clinic and small/medium hospital settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2017
MobileMedTek Bryan Ehret Director of Quality 1205 E. Washington St., Suite 115 Louisville, KY 40206
Re: K170441
Trade/Device Name: ElectroTek Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GWL Dated: May 4, 2017 Received: May 5, 2017
Dear Mr. Ehret:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170441
Device Name ElectroTek
Indications for Use (Describe)
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 scalp.
The ElectroTek is intended to be used for such studies as electroencephelogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter Information | |
|---|---|
| Name | MobileMedTek |
| Address | 1205 E. Washington St., Ste 115 |
| Louisville, KY 40206 | |
| Phone number | (866) 344-7839 x102 |
| Mobile number | (502) 644-3827 |
| Fax number | (502) 631-9843 |
| Name of contact person | Bryan Ehret, Director of Quality |
| Date prepared | June 5, 2017 |
| Name of device | |
| Trade or proprietary name | ElectroTek |
| Common or usual name | Electroencephalograph |
| Classification name | Full-Montage Standard Electroencephalograph, 21 CFR 880.1400, Class II |
| Amplifier, Physiological Signal, 21 CFR 882.1835, Class II | |
| Product Code(s) | GWQ |
| GWL | |
| Legally marketed device(s) to | |
| which equivalence is claimed | K143233 - Mistar EEG |
| K103140- Nicolet Wireless EEG | |
| K011204 – Neruofox, Models EEG-1100A, EEG-9100A | |
| Reason for 510(k) submission | New medical device intended for US commercial market. |
| Device description | The ElectroTek is a portable EEG system designed to improve the overall EEG test |
| experience for the patient, the electroneurodiagnostic technician running the EEG test, | |
| and the physician that reads the EEG results. The ElectroTek is optimized for fast | |
| setup with easy and intuitive use, resulting in improvements in overall usability at a | |
| lower total cost of ownership for an EEG system. The ElectroTek is designed to push | |
| data to the MobileMedTek Portal for secure archived data storage and remote viewing | |
| over the web by the reading physician. The ElectroTek's is used for routine EEG | |
| studies in outpatient clinic and small/medium hospital settings. The ElectroTek is also | |
| designed to be used in long term monitoring (LTM) conditions exceeding 24 hours per | |
| study. | |
| The ElectroTek EEG System is comprised of the case, device, custom hardware, the | |
| computing device, control software, firmware, peripheral devices, cables, and | |
| disposables. The peripheral devices include a Photic Stimulator for inducing seizure | |
| activity and a manually activated pushbutton Event Marker. Three primary Cables | |
| supplied by MobileMedTek as part of the ElectroTek include a Peripheral Cable that | |
| connects the Photic Stimulator to the ElectroTek Custom Hardware, the Event Marker | |
| cable that includes the handheld pushbutton and connects to the ElectroTek Custom | |
| Hardware, and a Patient Cable that includes a plug-in "yoke" box and connects to the | |
| ElectroTek Custom Hardware. Consumable Cables that will be supplied by | |
| MobileMedTek include four different electrode cables (the Sagittal (aka, "Midline") | |
| cable, the Parasagittal cable, the Transverse cable, and Individual cables. These cables | |
| are intended for re-use. The only single-use Disposables planned for the ElectroTek | |
| are the electrode cups that snap into the four consumable Cables and connect to the | |
| patient's head. | |
| Intended Use of Device | 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 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. |
K170441 510(k) Summary
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Image /page/4/Picture/0 description: The image contains the logo for MobileMedTek. The logo is in blue and black. The word "MobileMedTek" is written in a stylized font, with a heart rate line running through the bottom of the word.
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Image /page/5/Picture/0 description: The image shows the logo for MobileMedTek. The word "Mobile" is in a light blue color, and the word "MedTek" is in black. There is a line that starts under the word "Mobile" and extends to the right, ending in a sharp upward point under the "K" in "MedTek". The letters are large and bold.
| Summary of the technological characteristics of the device compared to the predicate device | ||||
|---|---|---|---|---|
| CHARACTERISTICS | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| MobileMedTek Holdings, Inc | ||||
| ElectroTek | ||||
| (K170441) | CareFusion 209, Inc. | |||
| Nicolet Wireless EEG Amplifier | ||||
| (K103140) | Mitsar Co., LTD | |||
| Mitsar-EEG | ||||
| (K143233) | Nihon Kohden America, Inc | |||
| EEG-1100A & EEG-9100A | ||||
| (K011204) | ||||
| 1. GENERAL - EEG | ||||
| 1.1 INDICATIONS FOR USE | The 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 Nicolet Wireless EEG Amplifier | |||
| is intended to be used as a front end | ||||
| amplifier to acquire, store and | ||||
| transmit electrophysiological signals | ||||
| in a wired or wireless mode for the | ||||
| Nicolet Neurodiagnostic system. | The Mitsar-EEG is intended to acquire, | |||
| display and store the electrical activity | ||||
| of a patient's brain obtained by placing | ||||
| two or more electrodes on the head to | ||||
| aid in diagnosis. | The EEG-1100a and EEG-9100a are | |||
| intended to record, measure and display | ||||
| the physiological data required for EEG | ||||
| and sleep studies (Polysomnography or | ||||
| PSG). This data may be used by the | ||||
| clinician in sleep disorders, epilepsies and | ||||
| other disorders as an aid in diagnosis. | ||||
| This device is intended for use by medical | ||||
| personnel and will be available for use | ||||
| within a medical facility or outside a | ||||
| medical facility under direct supervision | ||||
| of a medical professional. | ||||
| 1.2 WARNINGS | Items related to off-label use or | |||
| misuse | Items related to off-label use or | |||
| misuse | Items related to off-label use or misuse | Items related to off-label use or misuse | ||
| 1.3 CONTRAINDICATIONS | Items related to design and | |||
| indicated use limitations, such as, | ||||
| not for use in the presence of | ||||
| flammable anesthetics or in | ||||
| conjunction with defibrillation | ||||
| equipment. | Items related to design and indicated | |||
| use limitations, such as, not for use in | ||||
| the presence of flammable anesthetics | ||||
| or in conjunction with defibrillation | ||||
| equipment. | Items related to design and indicated | |||
| use limitations, such as, not for use in | ||||
| the presence of flammable anesthetics | ||||
| or in conjunction with defibrillation | ||||
| equipment. | Items related to design and indicated use | |||
| limitations, such as, not for use in the | ||||
| presence of flammable anesthetics or in | ||||
| conjunction with defibrillation equipment. | ||||
| 2. GENERAL - EEG | ||||
| 2.1 GENERAL SYSTEMS | ||||
| APPROACH | Computer based equipment with | |||
| dedicated hardware peripherals / | ||||
| components | Computer based equipment with | |||
| dedicated hardware peripherals / | ||||
| components | Computer based equipment with | |||
| dedicated hardware peripherals / | ||||
| components | Computer based equipment with dedicated | |||
| hardware peripherals / components | ||||
| 2.2 USER INPUT DEVICE | Window mouse / keyboard / touch | |||
| panel driven graphic interface with | ||||
| dedicated control panel | Window mouse / keyboard driven | |||
| graphic interface with dedicated | ||||
| control panel | Window mouse / keyboard driven | |||
| graphic interface with dedicated control | ||||
| panel | Window mouse / keyboard driven graphic | |||
| interface with dedicated control panel | ||||
| 2.3 USER OUTPUT DEVICE | Digital color display and optional | |||
| network printer connectivity | Digital color display and commercial | |||
| printers | Digital color display and commercial | |||
| printers | Digital color display and commercial | |||
| printers | ||||
| 2.4 PATIENT INPUTS | Up to 32 channels | Up to 32 channels | Up to 21 channels | Up to 32 channels |
| 2.5 SIGNAL ACQUISITION | Analog to digital conversion at | |||
| variable sample rate | Analog to digital conversion at | |||
| variable sample rate | Analog to digital conversion at variable | |||
| sample rate | Analog to digital conversion at variable | |||
| sample rate | ||||
| Summary of the technological characteristics of the device compared to the predicate device | ||||
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
| CHARACTERISTICS | MobileMedTek Holdings, Inc | |||
| ElectroTek | ||||
| (K170441) | CareFusion 209, Inc. | |||
| Nicolet Wireless EEG Amplifier | ||||
| (K103140) | Mitsar Co., LTD | |||
| Mitsar-EEG | ||||
| (K143233) | Nihon Kohden America, Inc | |||
| BEG-1100A & EEG-9100A | ||||
| (K011204) | ||||
| 2.6 TRIGGER INPUT | ||||
| (synchronization to external | ||||
| events) | Yes | Yes | Yes | Yes |
| 2.7 TRIGGER OUTPUT | ||||
| (synchronization to external | ||||
| events) | Yes | Yes | Yes | Yes |
| 2.8 USE OF STANDARD | ||||
| SOFTWARE PLATFORM | ||||
| (Operating System) | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows |
| 2.9 CUSTOMIZATION OF | ||||
| PROTOCOLS | Via storage / retrieval of user | |||
| defined settings | Via storage / retrieval of user defined | |||
| settings | Via storage / retrieval of user defined | |||
| settings | Via storage / retrieval of user defined | |||
| settings | ||||
| 2.10 APPLICATION | ||||
| FLEXIBILITY / | ||||
| EXPANDABILITY | Via software update | Via software update | Via software update | Via software update |
| 2.11 SAFETY STANDARDS | IEC 60601-1 ed3.1, | |||
| IEC 60601-1-2 ed3.0, | ||||
| IEC 60601-2-26 ed3.0. | ||||
| IEC 60601-2-40:1998, | ||||
| ISO 10993-1:2009 | UL 60601-1 | |||
| CAN/CSA-C22.2 No. 601.1-M90, | ||||
| EN/IEC 60601-2-26, | ||||
| EN/IEC 60601-1-2 | IEC 60601-1 ed3.1, | |||
| IEC 60601-2 | ||||
| IEC 60601-2-26 ed3.0. | ||||
| IEC 60601-2-40:1998, | ||||
| ISO 10993-1:2009 | IEC 60601-1:1988 + A1:1991+A2:1995, | |||
| IEC 60601-2-40: 1998. | ||||
| IEC 60601-1-1: ED.2: 2000, | ||||
| IEC 60601-1-2: ED.2:2001, | ||||
| EN 60601-1:1990 + A1:1993+A2:1995 | ||||
| EN 60601-1-1:2001 | ||||
| EN 60601-1-2:2001 | ||||
| CAN/CSA-C22.2 No. 601.1-M90 | ||||
| CAN/CSA-C22.2 No. 601.1S1-94 | ||||
| CAN/CSA-C22.2 No. 60601-1-1-02:2006 | ||||
| CAN/CSA-C22.2 No. 60601-2-40- | ||||
| 01:1998 | ||||
| CAN/CSA-C22.2 No. 601-1B-90:2002 | ||||
| 2.12 PATIENT CIRCUITRY | ||||
| ISOLATION | Transformer | Optic / transformer | Optic / transformer | Optic / transformer |
| 2.13 SYSTEM | ||||
| COMPONENTS | Base console including trigger | |||
| input/output, LED interface/photic | ||||
| stimulator; Control panel; internal | ||||
| amplifier; laptop computer with | ||||
| integrated display, USB video | ||||
| camera, keyboard and trackpad. | Base console including trigger | |||
| input/output, LED goggle | ||||
| interface/photic stimulator; Control | ||||
| panel; amplifier; computer, monitor, | ||||
| keyboard, mouse and printer. | Base console including trigger | |||
| input/output, LED goggle | ||||
| interface/photic stimulator; Control | ||||
| panel; amplifier; computer, monitor, | ||||
| keyboard, mouse and printer. | Base console including trigger | |||
| input/output, LED goggle interface/photic | ||||
| stimulator; Control panel; amplifier; | ||||
| computer, monitor, keyboard, mouse and | ||||
| printer. | ||||
| 2.14 SYSTEM - COMPUTER | ||||
| INTERFACE | USB | USB | USB | USB |
| Summary of the technological characteristics of the device compared to the predicate device | ||||
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
| CHARACTERISTICS | MobileMedTek Holdings, Inc | |||
| ElectroTek | ||||
| (K170441) | CareFusion 209, Inc. | |||
| Nicolet Wireless EEG Amplifier | ||||
| (K103140) | Mitsar Co., LTD | |||
| Mitsar-EEG | ||||
| (K143233) | Nihon Kohden America, Inc | |||
| EEG-1100A & EEG-9100A | ||||
| (K011204) | ||||
| 2.15 SYSTEM POWER | ||||
| SUPPLY | Mains (100-240 VAC) thru an | |||
| internal isolated power supply | Mains (100-240 VAC) thru an | |||
| isolation transformer | Mains (100-240 VAC) thru an isolation | |||
| transformer | Mains (100-240 VAC) thru an isolation | |||
| transformer | ||||
| 2.16 AMPLIFIER POWER | ||||
| SUPPLY | +/- 3 VDC from base console | 12 VDC from base console | 15 VDC from base console | 15 VDC from base console |
| 2.17 SIZE (L/W/D) cm | 53.10 x 26.95 x 4.45 cm (base | |||
| console + laptop lid closed) | 11.94 x 12.07 x 3.99 cm (ambulatory | |||
| recorder) | ||||
| 8.13 x 17.53 x 2.03 cm (patient | ||||
| connection unit) | 210 x 140 x 45 mm (amplifier) | 18.5 x 16.7 x 7.2 cm (Electrode Junction | ||
| Box) | ||||
| 2.18 WEIGHT kg | 3.987 kg (base console + laptop) | 0.43 kg (base console) | 600 g (amplifier) | 1.0 kg (base console) |
| 3. DESIGN - ACQUISITION - EEG | ||||
| 3.1 NUMBER OF | ||||
| CHANNELS | Up to 32 channels | Up to 32 channels | Up to 21 channels | Up to 32 channels |
| 3.2 CMRR Common Mode | ||||
| Rejection Ratio | > 110 dB | > 100 dB (with active patient ground | ||
| connected | > 100 dB @ 10 Hz | > 105 dB | ||
| 3.3 NOISE | 100 MΩ | > 100 MΩ | > 200 MΩ | > 100 MΩ |
| 3.5 LOW FILTER | 0.05 Hz to 39.8 Hz | Unknown | 0.016 to 70 Hz | 0.08 Hz (time constant: 2s) to 159 Hz |
| 3.6 HIGH FILTER | 1 Hz to 200 Hz | Unknown | Unknown | 300 Hz (-18 dB/oct.) |
| 3.7 NOTCH FILTER | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable |
| 3.8 A/D CONVERSION | 24 bit | 24 bit | 16 bit | 16 bit |
| 3.9 SAMPLING RATE | 500 Hz (EEG), 8KHz (impedance) | Up to 500 Hz | 500 Hz | Up to 1000 Hz |
| 3.10 TRIGGER MODE | Manual event marker | Manual event marker | Manual event marker | Manual event marker |
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Image /page/8/Picture/0 description: The image shows the logo for MobileMedTek. The logo is in blue and black, with the word "Mobile" in blue and the word "MedTek" in black. There is a blue line that runs under the words, and a black line that runs under the "Tek" in "MedTek". There is also a trademark symbol in the lower right corner of the logo.
Conclusion
The MobileMedTek ElectroTek meets the functional claims and intended use as described in the product labeling. The ElectroTek EEG device is substantially equivalent to the predicate devices.