(192 days)
Not Found
No
The summary describes a device that acquires and displays EEG signals in a compressed form (aEEG). It mentions standard signal processing and comparison to a predicate device, but there is no mention of AI, ML, or related concepts in the device description, performance studies, or training/test set descriptions.
No.
The intended use of the CerebraLogik is "to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form," which describes a diagnostic or monitoring function, not a therapeutic one. It does not provide any treatment or therapy.
Yes
The device is intended to "monitor the state of the brain by acquisition of EEG signals" and display them. While it doesn't explicitly state "diagnosis," monitoring brain states through physiological signals is a fundamental component of diagnostic processes when a clinician interprets those signals to identify or rule out conditions. The use in critical care settings also points to its role in assessing patient status, which aids in diagnostic decision-making.
No
The device description explicitly states that the CerebraLogik consists of a "dual channel EEG amplifier" and is connected via an "interface cable" to a "Mennen Medical patient monitor," indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- CerebraLogik's Function: The CerebraLogik acquires and displays in vivo (within the living body) physiological signals (EEG) directly from the patient's brain. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "to monitor the state of the brain by acquisition of EEG signals". This is a direct measurement of a physiological process within the body.
Therefore, based on the provided information, the CerebraLogik is a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.
The Intended Use of the CerebraLogik as indicated above is same as the Indications for Use.
Product codes (comma separated list FDA assigned to the subject device)
OMA, OMC
Device Description
The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor
The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG.
The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring
The patient monitors measure vital signs such as ECG/Heart rate, NIBP, SpO2, Temperature, Invasive pressures, Cardiac output and EtCO2 as an option.
The only change to the monitors is the modification of the software to allow the monitors to interface to the CerebraLogik aEEG modules to measure and display aEEG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intensive care unit, operating room, and for clinical research.
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
Bench test: Two types of bench testing of the subject and predicate device was performed. The first type compared amplifier characteristics of the devices. These tests included measurement and comparison of noise floors, input impedances, CMRR, and frequency responses. The second type of bench testing compared the output of the devices in a simulated use. In this test, EEG signal from Grass EEG Simulator model EEG SIM was inserted in parallel to both Olympic CFM 6000 and the CrebraLogik for periods of 3 hours. Both devices showed same aEEG graphs.
Animal Study: EEG signals of anesthetized piglets were recorded in parallel on Olympic CFM 6000 and the CerebraLogik for periods of 3 and 7 hours. EEG and aEEG recording changes caused by variation in ventilation and anesthesia during the test were compared and showed same aEEG pattern
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench test:
Two types of bench testing of the subject and predicate device was performed. The first type compared amplifier characteristics of the devices. These tests included measurement and comparison of noise floors, input impedances, CMRR, and frequency responses. The second type of bench testing compared the output of the devices in a simulated use. In this test, EEG signal from Grass EEG Simulator model EEG SIM was inserted in parallel to both Olympic CFM 6000 and the CrebraLogik for periods of 3 hours. Both devices showed same aEEG graphs.
Animal Study:
EEG signals of anesthetized piglets were recorded in parallel on Olympic CFM 6000 and the CerebraLogik for periods of 3 and 7 hours. EEG and aEEG recording changes caused by variation in ventilation and anesthesia during the test were compared and showed same aEEG pattern
Key results: The results confirm that the device under test, the CerebraLogik, is accurate and gave same results as the predicate device.
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).
0
Image /page/0/Picture/2 description: The image contains the logo for Mennen Medical. The logo consists of a circle with a stylized "m" inside, followed by the words "mennen medical" in a sans-serif font. The word "mennen" is on the top line, and the word "medical" is on the bottom line.
Date: Dec 25,2013
Topic: K131789- CerebraLogik - Traditional 510K for addition of aEEG to the Monitors family
Establishment Name, Registration Number and Address:
| Name: | Mennen Mec |
|---|---|
| Registration Number: | 9611022 |
| Operator Number: | 9069173 |
| Address: | 4 Hayarden S |
| Postal Address: | PO Box 102. |
| Tel: | +972-8-932- |
| Fax: | +972-8-932: |
| Contact person: | Ifat Shwarts. |
dical Ltd. Street, Yavne, 81228, Israel , Rehovot, 76100, Israel 3333 8210 , Regulatory Affairs
The following information is being submitted in conformance with 21 CFR 807.87:
- I. Classification Name Electroencephalograph 2. Classification Number: 21 CFR 882.1400 3. Common/Usual Name Electroencephalograph 4. Trade/Proprietary Name CerebraLogik 5. Part Number of CerebraLogik 681-138-010 6. Establishment Registration Number 9611022 7. FDA Classification Class II 8. Classification Product Code OMA, OMC 9. The Monitor Product Codes (VitaLogik) DSI23 10. Reviewing Panel Neurological 11. Performance Standards see page 8
1
Terminology
CerebraLogik aEEG - the monitor records EEG signals from two pairs of electrodes placed on the patient's head. The signal is filtered, rectified and compressed.
The CerebraLogik aEEG module will be interfaced to the VitaLogik monitor family, as below.
510(k) Marketing clearance for VitaLogik monitors:
VitaLogik 5000/5500 Patient Monitor = subject of this traditional 510(k). was approved for marketing by the FDA (K052288 - 20 Dec 2005)
VitaLogik 4000/4500 Patient Monitor = subject of this traditional 510(k). was approved for marketing by the FDA (K073140 - 21 Nov 2007)
VitaLogik 6000/6500 Patient Monitor = subject of this traditional 510(k). was approved for marketing by the FDA (K093766 - 7 May, 2010)
All monitors detailed above, belong to the same family, use the same menus and differ only in display size and packaging
All monitors detailed above, will be upgraded with the CerebraLogik module. The user will be able, in addition to existing capabilities, to also measure EEG signals and displays aEEG history.
Predicate Device
Olympic CFM 6000-K031149, cleared May, 14, 2003
1. Device Description: CerebraLogik
The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor
The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG.
The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring
2
Functional Description of the Monitors family
The patient monitors measure vital signs such as ECG/Heart rate, NIBP, SpO2, Temperature, Invasive pressures, Cardiac output and EtCO2 as an option.
The only change to the monitors is the modification of the software to allow the monitors to interface to the CerebraLogik aEEG modules to measure and display aEEG.
Substantial Equivalence: Comparison: CerebraLogik- aEEG with OLYMPIC CFM 2. 6000
Comparison between the intended use and indication for use:
| Intended/i | OLYMPIC CFM 6000 | CerebraLogik- aEEG |
|---|---|---|
| ndication | ||
| for use | K031149 | K131789 |
| Intended | ||
| for use | The Olympic CFM 6000 is intended to | |
| monitor the state of the brain by acquisition | ||
| of EEG signals in the intensive care unit, | ||
| operating room, and for clinical research. | CerebraLogik - aEEG | |
| The intended use of the | ||
| CerebraLogik is to | ||
| monitor the state of the | ||
| brain by acquisition of | ||
| EEG signals and display | ||
| the stored EEG in a | ||
| compressed form of | ||
| Amplitude Integrated | ||
| EEG - aEEG and in | ||
| conjunction with other | ||
| clinical data | ||
| Indication | ||
| for use | The Olympic CFM 6000is intended to be used | |
| by a variety of clinicians to acquire and utilize | ||
| SSG signals, when used in conjunction with | ||
| other clinical data, in intensive car areas, | ||
| Operating Room, Emergency Room, and | ||
| clinical research lab: |
- to monitor the state of the brain
- for determination of, and long-term
- monitoring of, the neurological status of
patients that may have suffered an
hypoxic-ischemic event. - For monitoring of neurological status to
- assist in the clinical management and
treatment of the patient by observing
how the treatment affects the
neurological status as shown by the | The Intended Use is same
as the Indications For Us |
3
Food and Drug Administration
Traditional 510(k) K131789 for CerebraLogik - addition of aEEG to the monitors family
| CFM | |
|---|---|
| - To assist in the predication of | |
| neurological outcome |
- To monitor and record frequency and
intensity of seizures in management of
anti-convulsive therapy. - To assist in the prediction of severity of
Hypoxic-Ischemic Encephalopathy and
long-term outcome in infants who have
suffered an hypoxic-ischemic event. |
Note: The term aEEG used by Mennen Medical is equivalent to the term CFM used by the Olympic CFM 6000
We have preferred to use the term aEEG to describe the Amplitude Integrated EEG since this is the generic term.
Conclusion of comparison of intended/indication for use:
The indication for use of both the CerebraLogik and the Olympic CFM 6000 (the predicate device) are not identical but have a similar content. Both devices intend to monitor the state of the brain by acquisition of EEG signals by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.
The following table compares the major elements in the CerebraLogik- aEEG vs. the OLYMPIC CFM 6000 (predicate device):
| Component | OLYMPIC CFM 6000 | CerebraLogik- aEEG |
|---|---|---|
| Principle of | ||
| Operation | Recording of EEG and | |
| storage and display of | ||
| Amplitude integrated | ||
| EEG | Same: | |
| Recording of EEG and storage and | ||
| display of Amplitude integrated EEG | ||
| Number of | ||
| channels | Single channel EEG & | |
| aEEG | Dual channel EEG & aEEG | |
| Number of | ||
| electrode inputs | 3 | 5 |
| Display size | 10" | 12" on VitaLogik 4000/4500 |
| 15" on VitaLogik 6000/6500 | ||
| 17" on VitaLogik 5000/5500 | ||
| aEEG Display area | 180 x 50 mm | On VitaLogik 4000/4500 |
| Single channel 180 x 50 mm | ||
| Dual Channel 180 x 35 mm | ||
| GUI | EEG + CFM {aEEG) | EEG + aEEG + VitaLogik Vital Signs |
| LAN | No | Yes |
| Touch screen | Yes (only) | Yes (optional) |
| Electrode quality | Resistance | Quality |
| Data storage | 20,000 hours of data | 3 patient , 7 days per patient |
| Output Storage | ||
| Device | CD-RW drive | USB (Data Storage Device) |
| Recorder | Built-in | Built-in (option) |
| RS-232 I/O port | ||
| Ethernet port | RJ-45 (10/100) Ethernet | |
| port | RJ-45 (10/100) Ethernet port | |
| Serial port | PS2 standard keyboard | |
| serial port (service only) | PS2 standard keyboard serial port | |
| Serial port | PS2 standard mouse | |
| serial port (service only) | PS2 standard mouse serial port | |
| Marker | Yes | Yes |
| Section selection | No | Yes |
| Amplifier** | ||
| EEG Noise floor | 1.5 micro Volt peak to | |
| peak | 1.5 micro Volt peak to peak | |
| aEEG Noise floor | 1.0-1.5 micro Volt peak to | |
| peak | 0.5-1 micro Volt peak to peak | |
| Input Impedance | ||
| active electrodes | 25 K Ohm | 600 K Ohm |
| Input Impedance | ||
| active electrodes to | ||
| reference | 200 K Ohm | 250 K Ohm |
| CMRR | 120DB | 110DB |
| Frequency | ||
| response | 2-15 Hz | Same, within + / - 2 dB |
4
Note: These values are measured values from bench testing of the subject and predicate devices
5
Summary of comparison tests
Bench test
Two types of bench testing of the subject and predicate device was performed. The first type compared amplifier characteristics of the devices. These tests included measurement and comparison of noise floors, input impedances, CMRR, and frequency responses. The second type of bench testing compared the output of the devices in a simulated use. In this test, EEG signal from Grass EEG Simulator model EEG SIM was inserted in parallel to both Olympic CFM 6000 and the CrebraLogik for periods of 3 hours. Both devices showed same aEEG graphs.
Animal Study
EEG signals of anesthetized piglets were recorded in parallel on Olympic CFM 6000 and the CerebraLogik for periods of 3 and 7 hours. EEG and aEEG recording changes caused by variation in ventilation and anesthesia during the test were compared and showed same aEEG pattern
The results confirm that the device under test, the CerebraLogik, is accurate and gave same results as the predicate device.
We consider the CerebraLogik- aEEG to be substantially equivalent to the OLYMPIC CFM 6000 and we submit that any differences between the two systems
· do not raise any new issues of safety and effectiveness
Reasons for change of Monitors family
Mennen Medical made the changes to the monitors' family for the following reasons:
- . As part of continuous improvement and innovation and in order to comply with market's requirements, Mennen Medical added the aEG parameter to its patient monitors family,
- The benefit of the incorporation of EEG and aEEG to the patient monitors is in the . synchronous monitoring, and storage, of the standard vital signs with the EEG waveform.
3. Detailed description of the changes made to the VitaLogik monitors to incorporate CerebraLogik
GUI
No changes were made to the GUI in the display or monitoring of standard vital signs.
For the display of EEG and aEEG an EEG menu was added, and display panels for single or dual channel EEG and aEEG real time and history were added.
6
Software
Software versions are the same for all VitaLogik monitors to ensure compatibility of all system components along the history of the system.
The change is limited to the addition of the CerebraLogik dual channel EEG amplifier, and use of algorithm for display of Amplitude Integrated EEG - aEEG
4. Verification, Validation and Testing
The CerebraLogik was tested in bench test and in animals by connecting in parallel the inputs of the Olympic CFM 6000 and the CerebraLogik.
Similar waveforms of both EEG and aEEG were received in these tests.
Internal tests called STD (Software Test Descriptions) were also performed on the CerebraLogik's software to ensure its verification and validation. The tests ensure the CerebraLogik aEEG monitor interfaces properly with the monitors and perform according its specifications.
ട. Proposed Labeling
The system will be called CerebraLogik and will be added to the VitaLogik monitors.
We have assigned a new Part Number to the CerebraLogik P/N 681-138-010
User Manuals of each of the monitors will have a chapter describing the use of the CrebraLogik.
Page 1-1 of the introduction to the VitaLogik (6000&4X00) User Manuals contains the following Prescription Notice: "Caution: Federal law restricts this device to sale by or on the order of qualified medical personnel only."
The following symbols appear on page 2-5 of the User Manuals and/or on the side panel of the VitaLogik/CerebraLogik accordingly.
"Attention - see Accompanying Instructions for Use"
Image /page/6/Picture/15 description: The image shows a black and white drawing of a triangular warning sign. Inside the triangle is a large exclamation point. The exclamation point is centered within the triangle and is the most prominent feature of the image. The sign is simple and easily recognizable as a warning symbol.
Type BF Applied part (next to NIBP, SpO2, Temperature and EtCO2 connectors )
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Image /page/7/Picture/1 description: The image shows a black and white drawing of a person inside of a square. The person is standing with their arms outstretched to the sides and their legs apart. The person is a simple stick figure with a circle for a head and lines for the arms and legs. The square is a simple black line.
TYPE BF APPLIED PART
Image /page/7/Picture/3 description: The image shows a black and white drawing of a heart inside of a square. There are two symbols on either side of the square. The symbols are a vertical line with a horizontal line through the middle.
Type CF Applied Part - Defibrillation Proof (next to ECG, IBP and CO connector)
Symbols and labeling
Voluntary Standards 6.
Appropriate voluntary standards for this device, to which conformance have been
demonstrated:
-
- IEC 60601-1: (2005) Medical Electrical Equipment Part: 1 General Requirements for Safety
-
- IEC 60601-1-1 (2000) Medical Electrical Equipment Part 1-1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems
-
- IEC 60601-1-2 (2007): Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- ゃ IEC 60601-2-27 (2005): Medical electrical equipment. Part 2. Requirements for safety of electrocardiograph monitoring equipment.
-
- IEC 60601-2-30 (1999): Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment
-
- IEC 60601-2-34 (2005): Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment
-
- IEC 60601-2-49 (2001): Particular Requirements for the safety of multifunction patient monitoring equipment
- ゃ IEC 60601-2-26 ed3.0 (2012): Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
8
Indication for use 7.
Monitor's Indications for Use (unchanged since latest approval: VitaLogik 6000 K093766, 7 May, 2010):
The VitaLogik is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik can monitor ECG/heart rate, invasive blood pressure channels, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2.
This effectively allows the VitaLogik to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical VitaLogik is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
-
- Critical Care Patients
-
- Cardiac Step-down/Telemetry Units
-
- Emergency Departments
-
- Intra .- operative (Anesthesia) Monitoring
-
- Post Anesthesia Care
CerebraLogik - aEEG
The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.
*The Intended Use of the CerebraLogik as indicated above is same as the Indications for Use.
Signature:
Heto Iner
Ifat Oren Shwarts
QA & Regulatory manager
Mennen Medical Ltd. +972-8-9323333 ext. 213 Tel: Fax: +972-8-9328510 E-mail: Ifat_oren@mmi.co.il
Image /page/8/Picture/20 description: The image shows a circular seal with the text "MENNEN MEDICAL LTD. ISRAEL" arranged in a circular fashion. The text is slightly distorted, giving it a stamped appearance. The seal has a jagged edge, resembling a perforated or rough border.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenus Document Control Center - WO66-G60 Silver Spring MD 20993-0002
December 27, 2013
Mennen Medical, Ltd. Ms. Ifat Shwarts QA and Regulatory Manager 4 Hayarden Street, Yavne P.O. Box 102 Rehovot, Israel, 76100
Re: K131789
Trade/Device Name: CerebraLogik aEEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroenchphalograph Regulatory Class: Class II Product Code: OMA, OMC Dated: November 21, 2013 Received: November 27, 2013
Dear Ms. Shwarts:
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. Iisting 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
10
Page 2 - Ms. Ifat Shwarts
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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 yours.
Image /page/10/Picture/7 description: The image shows the name "Carlos L. Pena -" in a bold, sans-serif font. The letters are black against a white background. The "L" in the middle name is stylized with a dotted pattern.
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known):
Device Name:
. : 、ジェ
CerebraLogik aEEG
Indications For Use:
The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Carlos Pena -S
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