(133 days)
Not Found
No
The summary describes a device for acquiring, displaying, storing, and archiving electrophysiological signals. It focuses on hardware performance and compliance with electrical safety and electromagnetic compatibility standards. There is no mention of AI, ML, or any analytical capabilities beyond signal acquisition and display.
No.
The device is intended for acquiring, displaying, storing, and archiving electrophysiological signals (EEG and PSG) for diagnostic and monitoring purposes, not for providing therapy.
Yes
The device is an electroencephalograph (EEG), which acquires electrophysiological signals to assist in diagnosis. The "Intended Use / Indications for Use" section explicitly states its purpose is to "acquire, display, store and archive electrophysiological signals," which are then used by trained medical professionals in clinical environments for diagnostic purposes.
No
The device description explicitly states that the system is comprised of a "base unit and a breakout box" and includes "sensor inputs," "integrated pressure sensor and pulse oximeter module," and other hardware components like a personal computer, photic stimulator, etc. While software is mentioned as part of the system, the device itself is a hardware amplifier.
Based on the provided text, the Natus Brain Monitor Amplifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to acquire, display, store, and archive electrophysiological signals (EEG and PSG) from the human body. This involves measuring electrical activity within the body, not analyzing samples outside the body.
- Device Description: The description details how the device acquires signals from electrodes placed on the head and body, as well as other physiological sensors. This further reinforces that it's interacting directly with the patient's body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
Therefore, the Natus Brain Monitor Amplifier is a medical device used for physiological monitoring, specifically electroencephalography and polysomnography, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/ SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
Product codes (comma separated list FDA assigned to the subject device)
GWO, OLV
Device Description
The Natus Brain Monitor family of amplifiers are intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
The Natus Brain Monitor family of amplifiers are intended to be used by trained medical professionals, and are designed for use in clinical environments such as hospital rooms, clinics, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
The Natus Brain Monitor (Natus Embla NDx, Natus Embla SDx) are comprised of a base unit and a breakout box. It is part of a system that is made up of a personal computer, software, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports.
EEG and other physiological signals from electrodes placed on the head and body as well as other accessories such as pulse oximeters, respiratory effort and airflow sensors can be acquired by the amplifiers. The amplifiers include sensor inputs for respiratory effort and airflow as well as snoring. The amplifiers include an integrated pressure sensor and pulse oximeter module. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks/SleepWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.
The Natus Brain Monitor and Natus Embla NDx are identical devices. The only difference is the brand name/label on the front face of the breakout box. The Natus Embla SDx is a limited functionality version of the Natus Embla NDx with fewer inputs and some features turned off.
Natus Brain Monitor features include:
- Up to 64 AC inputs (40 referential, and 24 referential/differential configurable)
- Up to 16 DC channels (12 on Natus Base unit + 4 on Brain Monitor & Embla NDx Breakouts)
- Integrated Pulse Oximeter including SpO2, Pulse Rate and Plethysmogram signals
- Ability to initiate an impedance test, change the threshold, and view the results in the patient room
- Digital Trigger Input
- A small and lightweight breakout box
- TCP/IP and USB connectivity
- Patient-event switch interface on both the breakout box and base units
- Photic stimulator interface for EEG applications (excluding Embla SDx).
- Holster for cart mounting
- Pouch for extended EEG studies
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp, Intracranial, Thorax/Abdomen, Nasal/Oral, Finger, Nasion/cheek/chin or side of the neck
Indicated Patient Age Range
All ages, but not designed for fetal use.
Intended User / Care Setting
Trained medical professionals / clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms.
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)
The Natus Brain Monitor was verified for performance in accordance with Electrical Safety the following standard:
- IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
Results indicate that the Natus Brain Monitor complies with the applicable standards.
The Natus Brain Monitor was verified for performance in accordance Electromagnetic with the following standard: Compatibility
- IEC 60601-1-2Edition4.0 : 2014-02, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs.
Results indicate that the Natus Brain Monitor complies with the applicable standards.
The Natus Brain Monitor was verified for EEG hardware performance in Performance accordance with internal requirements and the applicable clauses of the Testing - Bench following standards:
- IEC 60601-1-6 Edition 3.1: 2013-10, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability.
- IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs.
- IEC 62366: 2007, Am1: 2014, Medical devices – Application of usability engineering to medical devices.
- ISO 80601-2-61 : 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
The bench testing was performed to confirm
- EEG hardware Signal Quality such as leakage, noise, signal range, offset, CMRR, input impedance and cross talk.
- Functional testing of the Amplifier with NeuroWorks/SleepWorks software
- Device performance at extreme Environmental and storage limits
- Functional testing of the Amplifier with various accessory such as various type of Electrodes, Xactace belts, Thermistor ,Photic stimulators etc.
Results indicate that the Natus Brain Monitor complies with its predetermined specifications and the applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2018
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta Director, Quality Assurance & Regulatory Affairs 2568 Bristol Circle Oakville, ON L6H 5S1 Canada
Re: K180290
Trade/Device Name: Natus Brain Monitor, Embla Dx series Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. OLV Dated: March 15, 2018 Received: March 16, 2018
Dear Sanjay Mehta:
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 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);
1
Page 2 - Sanjay Mehta
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -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
2
Indications for Use
510(k) Number (if known) K180290
Device Name Natus Brain Monitor, Embla Dx series
Indications for Use (Describe)
The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/ SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal color and in a larger font. Below that, the word "neurology" is in a smaller, black font. There is a registered trademark symbol to the right of the word "natus".
510K Summary
Date: May 24, 2018
- Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
- Contact Person: Sanjay Mehta Director, Quality and Regulatory Affairs Natus Medical Incorporated Tel.: (905) 829-5300 ext 388 Fax.: (905) 829-5304 E-mail: sanjay.mehta@natus.com
Proprietary Name: Natus Brain Monitor, Embla Dx series (includes models Embla NDx & Embla SDx)
Common Name: Electroencephalograph
Regulation Number : 21CFR 882.1400
Classification Name: Standard Polysomnograph with Electroencephalograph
Product code: GWQ, OLV
Device Class: II
Predicate Device: Natus Quantum (K143440); N7000 System (K111742), Comet-Plus (K172711)
Description:
1. Overview: Natus Brain Monitor
The Natus Brain Monitor family of amplifiers are intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
The Natus Brain Monitor family of amplifiers are intended to be used by trained medical professionals, and are designed for use in clinical environments such as hospital rooms, clinics, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
4
Image /page/4/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a smaller, italicized, black sans-serif font. The logo is simple and clean, with a focus on the company name.
2. Operating Principle of the Quantum Amplifier
The Natus Brain Monitor (Natus Embla NDx, Natus Embla SDx) are comprised of a base unit and a breakout box. It is part of a system that is made up of a personal computer, software, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports.
EEG and other physiological signals from electrodes placed on the head and body as well as other accessories such as pulse oximeters, respiratory effort and airflow sensors can be acquired by the amplifiers.` The amplifiers include sensor inputs for respiratory effort and airflow as well as snoring. The amplifiers include an integrated pressure sensor and pulse oximeter module. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks/SleepWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.
Image /page/4/Picture/5 description: The image shows two Natus neurology devices, one labeled as a "Brain Monitor" and the other as "Embla". The Brain Monitor device has a screen displaying the Natus neurology logo and the words "Brain Monitor". Next to it is a smaller device with numerous buttons and connection points, also bearing the Natus logo. The Embla device is similar in appearance to the Brain Monitor, with a screen displaying the word "Embla".
2.1. Brain Monitor
Image /page/4/Picture/7 description: The image shows three Natus Neurology medical devices. The device in the center is a larger, square-shaped monitor with a screen displaying the text "Embla NDx". The device on the right is a smaller, rectangular monitor with various buttons and indicators. The device on the left is similar to the one on the right, but only a portion of it is visible.
2.2. Embla NDx
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Image /page/5/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color, with a registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a dark red color. The logo is simple and modern.
2.3. Embla SDx
Image /page/5/Picture/3 description: The image shows two Natus Neurology Embla SDx devices. The device on the left is larger and has a screen displaying the Embla SDx software interface. The device on the right is smaller and has a screen displaying a diagram of electrode placement on a human body. Both devices have the Natus Neurology logo.
The Natus Brain Monitor and Natus Embla NDx are identical devices. The only difference is the brand name/label on the front face of the breakout box. The Natus Embla SDx is a limited functionality version of the Natus Embla NDx with fewer inputs and some features turned off.
Natus Brain Monitor features include
- Up to 64 AC inputs (40 referential, and 24 referential/differential configurable) ●
- Up to 16 DC channels (12 on Natus Base unit + 4 on Brain Monitor & Embla NDx Breakouts) ●
- Integrated Pulse Oximeter including SpO2, Pulse Rate and Plethysmogram signals ●
- Ability to initiate an impedance test, change the threshold, and view the results in the patient room
- Digital Trigger Input ●
- A small and lightweight breakout box ●
- TCP/IP and USB connectivity
- . Patient-event switch interface on both the breakout box and base units
- Photic stimulator interface for EEG applications (excluding Embla SDx).
- . Holster for cart mounting
- Pouch for extended EEG studies
6
Image /page/6/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, sans-serif font.
System Setup Overview
The Natus Brain Moniotr family of amplifiers connects to the Natus NeuroWorks (K090019) & Natus SleepWorks (K090277) software for the acquisition storage, analysis, and review of Electroencephalographic & Polysomnographic data in conjunction with synchronized digital video. The system overview is as follows.
Image /page/6/Figure/4 description: This image shows a diagram of a brain monitoring system. The diagram includes a patient connected to various devices such as electrodes, an oximeter, and thorax/abdominal belts. These devices are connected to a Natus Base, which includes a CPU and AC-DC converter, and a personal computer running NeuroWorks/SleepWorks software. The system also includes an isolation transformer, AC mains, and various isolation barriers to ensure patient safety.
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Image /page/7/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with the "us" connected. Below that, the word "neurology" is in a smaller, black, italicized sans-serif font. The logo is simple and modern.
Device-patient interaction Accessories List:
The table below lists all accessories to the subject device. Accessories (1) to (7) enter in contact with the patient. These sensors guarantees acquisition of the physiological signals and passively transfer them to the head box. Characteristics of the sensors vary and are described (cleared) under their respective 510K submissions (see table).
| | Description | Body contact
location | Device connection/Usage |
|----|-------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Reusable gold disk
electrode (K982053) | Scalp (according to
10-20 & 10-10
system) | Referential and differential inputs
Usage: To record the EEG/EOG/EMG surface
potentials. |
| 2 | Single Use Intracranial
Grids, Strips and
Depth Electrodes
(K082474) | Intracranial
recordings | Referential and differential inputs (labeled
numerically)
Usage: For the recording, monitoring and stimulation
of electrical signals. |
| 3 | Xactrace (K043132) | Respiratory belts
Thorax/Abdomen | Sensor input
Usage: to measure respiratory effort signals |
| 4 | Thermistor (K922112) | Nasal/Oral | DC input
Usage: to monitor breathing frequency |
| 5 | Pulse Oximeter Sensor
(K092101) | Finger | Channel labeled “oximeter/photic”
Usage: non-invasive spot-checking and/or continuous
monitoring of adult and pediatric patients who are well
or poorly perfused |
| 6 | Snoring microphone
(K941759) | Nasion/cheek/chin or
side of the neck | DC input
Usage: To monitor breathing frequency |
| 7 | Cannula (K922112) | Nasal/Oral | Pressure input
Usage: To monitor breathing frequency |
| 8 | Body position Pod
(K122516) | Thorax | Sensor input
Usage: Position or movement recording |
| 9 | Photic Stimulator
(K991903) | None | Photic input (base unit)
Usage: For photic activation of the EEG in visual
evoked potential |
| 10 | Holster/Mounting
arm/Roll Stand (510K
-Not applicable) | None
Back/shoulder straps | None
Usage: Used to attach Quantum breakout boxes in as a
backpack to keep them out of the way of the patient. |
| 11 | Pouch (510K# Not
Applicable) | None | None
Usage: To keep the breakout and electrodes protected
and easy to move. |
| 12 | XLTEK Trolley and
Carts (510K# Not
Applicable) | None | None
Usage: Cart optimized for sitting users on which the
recording computer resides |
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Image /page/8/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black sans-serif font.
Indications for Use
The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
Comparison to Predicate Device
| Specification | Predicate Device | Predicate Device | Predicate Device | Subject Device |
|---|---|---|---|---|
| Natus Quantum | ||||
| (K143440) | N7000 System (K111742) | Comet-PLUS | ||
| (K172711) | Natus Brain Monitor | |||
| Model #1: Natus Brain | ||||
| Monitor | ||||
| Model #2: Natus | ||||
| Embla NDx | ||||
| Model #3: Natus | ||||
| Embla SDx | ||||
| Manufacturer | Natus Medical | |||
| Incorporated | ||||
| Dba. Excel Tech Ltd | ||||
| (Xltek) | Embla Systems a | |||
| division of Natus Medical | ||||
| Incorporated | Natus Medical | |||
| Incorporated | ||||
| Dba. Excel Tech Ltd | ||||
| (Xltek) | Natus Medical | |||
| Incorporated | ||||
| Dba. Excel Tech Ltd | ||||
| (Xltek) | ||||
| Referential | ||||
| Channels | 256 | |||
| 128 per Breakout | 32 | 32 | 40 (programmable to up | |
| to 64) | ||||
| 16 (Embla SDx Model) | ||||
| Bipolar | ||||
| Channels | 16 | |||
| 8 per Breakout | 8 | 8 | 12 | |
| 4 (Embla SDx Model) | ||||
| DC inputs | 16 (+/-5Vdc) | 8 (+/-5Vdc) | 8 (+/-2.5Vdc) | 16 (+/-5Vdc) |
| 8 (+/-5Vdc) - For Embla | ||||
| SDx model | ||||
| SpO2 | SpO2, Pulse Rate, | |||
| Plethsmogram | SpO2, Pulse Rate, | |||
| Plethsmogram | SpO2 Pulse Rate, | |||
| Plethsmogram, PPG | SpO2 Pulse Rate, | |||
| Plethsmogram, PPG | ||||
| Body Position | Uses a universal sensor via | |||
| DC input | Integrated Proprietary | Uses a universal sensor | ||
| via DC input | Integrated proprietary | |||
| Resolution | 24 bit (16 bit stored) | 22 bit | 16 bit | 24 bit (16 bit stored) |
| EEG Channels | 64-256 | 40 | 32 | 64 |
| 20 (Embla SDx) | ||||
| Reference | ||||
| Channels | Dedicated separate | |||
| reference and ground | Dedicated ground | Dedicated separate | ||
| reference and ground | Dedicated separate | |||
| reference and ground | ||||
| Input | ||||
| Impedance | >1000 MOhm | >20MΩ | ≥20 ΜΩ | >1000 MOhm |
| Input Noise | 110dB@60Hz | >80dB | >80 dB (signal ref), > 100 | |
| dB (earth ref) | >106db@60Hz | |||
| Sampling | ||||
| Frequency | 256, 512, 1024, 2048, | |||
| 4096, 8192, 16384 Hz | 64, 128, 256, 512Hz | 200 Hz, 256 Hz, 400 Hz, | ||
| 512 Hz, 800 Hz | 256, 512, 1024, 2048, | |||
| 4096 | ||||
| 256, 512Hz (Embla SDx) | ||||
| Sampling | ||||
| Resolution - | ||||
| EEG channels | 24 bits | 22 bits | 16 bits | 24 bits |
| Sampling | ||||
| Quantization - | ||||
| EEG channels | 305nV | N/A | 0.06 µV/bit | 305nV |
| Storage | ||||
| Resolution - | 16 bits | 16 bits | 16 bits | 16 bits |
| Impedance | ||||
| Check |