The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.

Device Description

Dizziness and postural instability are common in patients in Otolaryngology practice. Accurate diagnosis and choice of treatment is hampered by difficulties in obtaining thorough histories and perceptions that physical examination is complex. The DizzyDoctor® System 1.0.0 broadens physician access to video recordings of abnormal eye movement disorders with an easily operated device for in-office use by health professionals and for in-home use by patients experiencing exacerbating episodes of dizziness outside the office setting.

Using mobile and web-based technology, The DizzyDoctor® System 1.0.0 allows recording of patient of abnormal eye movements in response to standard head positions used for monitoring peripheral vestibular disorders such as Benign Paroxysmal Vertigo. It consists of Vertigo Recording Googles (VRG) with a secure holder for the patient's iPhone Application for step-by-step audio instructions for medically-recognized Dix-Hallpike maneuvers, gyroscopic feedback for enabling correct head positioning, and accurate video-recording of eye movements in response to standard head positions used for assessing balance disorders.

The VRG secure docking station for the iPhone which aligns with the patient's pupil. The VRG has no direct electrical connection with external devices or equipment, and uses light from two LEDs during recording sessions. The VRG uses a standard iPhone compatible macro lens to adjust the focal length of the iPhone camera lens, and secures with a flexible headband.

Key components of the patient's iPhone support the DizzyDoctor® System 1.0.0 including: an accelerometer and gyroscope, a video camera, storage of video recordings, audio voice/speaker system for real-time interaction with the patient, standard software for downloading and playing mobile applications from external App vendors, software for web-based processes including uploading stored videos.

The DizzyDoctor® Mobile App provides audio support for step-by-step procedures in recording eye movements in relation to positional changes during self-testing, The DizzyDoctor® System is supported by a comprehensive web-based platform for secure patient and physician registration, as well as uploading, processing and downloading videos from the professional- and self-testing for abnormal eye movements. Processed videos are accessed and viewed by physicians on their desk-top office computers.

AI/ML Overview

The provided document is a 510(k) summary for the DizzyDoctor® System 1.0.0, an Eye Movement Monitor. It details the device, its intended use, and comparative performance testing against a predicate device. However, it does not contain a specific table of acceptance criteria for algorithm performance (such as sensitivity, specificity, or AUC) or a dedicated study section proving the device meets such criteria in the manner typically seen for AI/ML device submissions.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through various types of testing, including:

Biocompatibility testing
Software verification and validation
Usability/human factors (engineering) testing
Performance, electrical safety, and electromagnetic compatibility (EMC) testing

The "Usability/human factors (engineering) testing" section is the closest to addressing performance with human factors, but it doesn't provide precise quantitative acceptance criteria or detailed results in the format requested for AI/ML performance.

Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document in the format of AI/ML metrics. Similarly, direct answers to many of the subsequent questions (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type for test set/training set, training set size) are not explicitly stated for an AI/ML component's performance study because the submission does not describe an AI/ML algorithm being validated in that manner for medical device functionality.

Here's what I can extract and infer based on the provided text, particularly focusing on the "Usability/human factors (engineering) testing" section, as it's the most relevant to a performance evaluation of the device in a user context:

Summary of Device Performance and Testing from the Document (as it pertains to functionality and usability, not AI/ML algorithm performance verification):

The DizzyDoctor® System 1.0.0 is an Eye Movement Monitor indicated for detecting abnormal eye movements in standard positional maneuvers by recording, tracking, storing, and displaying vertical, horizontal, and torsional eye movements. It is designed for use in medical offices and in the home setting for patients with dizziness caused by peripheral vestibular disorders. The device provides no diagnosis and does not provide diagnostic recommendations.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not specify acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The performance evaluations described are related to usability, safety, and functional equivalence to a predicate device. The closest to "performance" in a clinical context within this document is the usability study with audiologists assessing eye movement recordings.

Performance Aspect (Inferred from Usability Studies)	Acceptance Criteria (Inferred)	Reported Device Performance
User interface task completion (Study 1, 3)	Competent completion, ability to self-correct if difficulties arise	Subjects completed tasks competently. Two subjects had difficulty but self-corrected and completed setup, self-test, and after-test activities completely and accurately. All subjects accomplished operational tasks after a software revision (Study 3).
Agreement on pathological nystagmus (Study 2)	100% agreement between audiologists on presence/absence of pathological nystagmus from DizzyDoctor® System and predicate device recordings	Audiologists agreed 100% of the time with respect to the presence or absence of pathological nystagmus in video recordings from the subject and predicate devices.

2. Sample Sizes Used for the Test Set and Data Provenance:

Study 1 (Usability):
- Sample Size: 30 subjects (10 vertiginous, 10 non-vertiginous users, plus unspecified number for general usability as implied by comprehensive task evaluation).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It appears to be prospective usability testing.
Study 2 (Clinical Performance/Usability):
- Sample Size: Number of subjects from whom eye movement recordings were evaluated is not specified (e.g., "the subject and predicate devices").
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
Study 3 (Usability/Software Revision):
- Sample Size: 5 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It appears to be prospective usability testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Study 2: Two audiologists were used to evaluate eye movement recordings and nystagmographs from both the DizzyDoctor® System and the predicate device.
Qualifications: "Audiologists" are specified. Further details on their experience (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set:

Study 2: The method was a direct comparison of agreement. "The results indicated that the audiologists agreed 100% of the time with respect to the presence or absence of pathological nystagmus in the video recordings from the subject and predicate devices." This implies that they reached 100% agreement, so no specific adjudication method (like 2+1 or 3+1) was necessary to resolve discrepancies, as there were none reported for the specific assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

An fMRMC study (where "f" denotes "free-response") was not explicitly conducted as a formal comparative effectiveness study where human readers improve with AI assistance.
However, Study 2 involved two audiologists evaluating recordings, which has elements of a multi-reader study. The comparison was between devices (DizzyDoctor® vs. predicate) and the audiologists' agreement on pathological nystagmus, not an assessment of AI assistance improving human reader performance. The device itself is an "Eye Movement Monitor," not an AI diagnostic tool providing interpretations to a human. There is no mention of an effect size for human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document describes the DizzyDoctor® System 1.0.0 as an "Eye Movement Monitor" that detects, records, tracks, stores, and displays eye movements. It explicitly states: "This device provides no diagnosis and does not provide diagnostic recommendations." This indicates that the device's function is primarily data capture and display, not an AI algorithm providing a standalone diagnostic output. Therefore, a standalone performance study of an AI algorithm is not relevant or described in this submission.

7. The Type of Ground Truth Used:

Study 2: The ground truth for the presence or absence of pathological nystagmus was established by the consensus/agreement of two audiologists, who viewed recordings from both the DizzyDoctor® System and the predicate device. This aligns with "expert consensus" as a type of ground truth.

8. The Sample Size for the Training Set:

The document describes software verification and validation, but it primarily focuses on the device's functional performance, usability, and regulatory compliance, not on an AI/ML model that would require a distinct "training set" in the common sense of machine learning. Therefore, a sample size for a training set is not applicable or provided in this document as it doesn't detail an AI/ML algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable as the document does not describe the training of an AI/ML model for diagnostic or interpretive purposes. The "software revision" mentioned in Study 3 seems to be a general software update validated for usability, not an iterative improvement of an AI model's performance based on ground truth data.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2018

DizzyDoctor® Systems, LLC % Mark Job Responsible Third Party Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K182214

Trade/Device Name: DizzyDoctor® System 1.0.0 Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: June 2, 2018 Received: August 15, 2018

Dear Mark Job:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm_identifies combination product submissions. 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.

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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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html: good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 yours,

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182214

Device Name DizzyDoctor® System 1.0.0

Indications for Use (Describe)

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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510(k) Summary

Date of Summary Preparation: 06/02/2018

1. Submitter Information

DizzyDoctor® Systems, LLC 7625 Mesa College Drive, Suite 200A San Diego, CA 92111

Tel: (858) 223-2172 Contact: Ian Purcell MD, PhD

2. Device Identification

Proprietary Name:	DizzyDoctor® System 1.0.0
Common Name:	Eye Movement Monitor
Classification Name:	Nystagmograph (21CRF 882.1460)
Product Code:	GWN
Device Class:	Class 2
Panel:	Neurology
3. Predicate Devices:	VisualEYES Video Eye Monitor; K964325; 07/15/1997

Micromedical Technologies.

Indications for Use: The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in response to standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal and torsional eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.

Device Description: Dizziness and postural instability are common in patients in Otolaryngology practice. Accurate diagnosis and choice of treatment is hampered by difficulties in obtaining thorough histories and perceptions that physical examination is complex. The DizzyDoctor® System 1.0.0 broadens physician access to video recordings of abnormal eye movement disorders with an easily operated device for in-office use by health professionals and for in-home use by patients experiencing exacerbating episodes of dizziness outside the office setting.

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recording sessions. The VRG uses a standard iPhone compatible macro lens to adjust the focal length of the iPhone camera lens, and secures with a flexible headband.

VisualEyes Video Monitor	DizzyDoctor® System 1.0.0 eyemovement monitor	Assessment of SubstantialEquivalence
Anatomical Site:
Human Eye	Human Eye	Same
Intended Use:
Support evaluation anddiagnosis of vestibular disordersfrom observation of eyemovements from various stimuli	Support evaluation anddiagnosis of vestibular disordersusing standard positionalmaneuvers.	Same with respect to stimulifrom positional maneuvers.
Indications for Use:
The Eye Movement Monitor isused to observe eye movementsfrom various stimuli used investibular diagnostic testing. Itallows observation of horizontal,vertical and torsional eyemovements.	The DizzyDoctor® System 1.0.0is indicated for use in the med-ical office, and in the homesetting for patients with adiagnosis of dizziness caused byperipheral vestibular disorderswho are under the supervision ofa physician. The device detectsabnormal eye movements inresponse to standard positionalmaneuvers by recording,tracking, storing and displayingvertical, horizon-tal andtorsional eye move-ments. Thisdevice provides no diagnosisand does not provide diagnosticrecommendations.Caution: Federal law restrictsthis device to sale by or on theorder of a physician.	Substantially equivalent, exceptfor the following differences.DDS 1.0.0 is intended for use inthe medical office as well as bythe patient in the home setting,as prescribed by the patient'sdoctor. The predicate device isnot used in the home setting.DDS 1.0.0 is indicated formonitoring in patients with adiagnosis of peripheralvestibular disorders.DDS 1.0.0 does not supportcaloric testing; the predicatecan.DDS 1.0.0 is a monoculardevice; the predicate ismonocular and binocular.DDS 1.0.0 uploads videos ofeye movement testing in themedical office or home settingsdirectly to the DDS website forviewing by patients or patient's
		physician. For the predicateaccess is limited to the doctor,and remote access to remote in-home testing observations is notpossible.
Intended Use:For observing eye movementsduring vestibular testing tosupport diagnostic testing ofvestibule-ocular disorders.	For observing eye movementsduring vestibular testing tosupport diagnostic testing ofvestibule-ocular disorders.	Substantially equivalent
Mechanical Construction:A light occluding goggle frameon which a small camera viewsthe eye.	A light occluding goggle frameon which a small camera viewsthe eye.	Substantially equivalent
Method of Viewing:Monocular or binocular	Monocular	Substantially equivalent
LED side-lightsBuilt in light shielding to blockexternal light	LED side lights built into goggleBuilt-in light shielding to blockexternal light	Substantially equivalent
Viewed by direct observationoptionally on video tape withseparate device	Viewed on physician's officecomputer or laptop and patient'scomputer	Substantially equivalent
Power Source/Control:Mains/electrical outlet	CR2 3V battery	Substantially equivalent
On/off button switch on goggles tostart, stop and abort recordingsduring Dix-Hallpike and PositionalTests.	Button switch on googles to turnLED illumination on/off. Buttonon iPhone mounted on googleallows on/off control duringrecording sessions.	Substantially equivalent
Camera:Cameras mounted on top of gogglesand close to the forehead	Camera is in patient's orphysician's iPhone, which isaffixed at eye level eye to thegoggle's Mounting Plate thataligns the iPhone camera to thepatient's eye.	Substantially equivalent
Remote Access to Recordings:Not available	Remote access to eye movementvideos recorded in the homesetting through uploads from thepatient's iPhone to the DDSwebsite which can be down-loaded by patients and theirphysicians.	Different
Human Factors:
Physician or technician guidedtesting in the medical office	Physician or technician guidedtesting for first use of the VRG,and helper-guided testing for in-home setting	Substantially equivalentFor remote recording in thehome setting, the patient'shelper is trained at the doctor'soffice, and supported by audio-instructions on the iPhoneduring positional maneuvers andeye movement recoding.
American National StandardInstitute (ANSI) Proceduresfor Testing Basic VestibularFunction.
Not reported for predicate bymanufacturer	Conformance by comparativeperformance testing of DDS1.0.0 with predicate for position-ing and positional Nystagmus.ANSI S3.45-2009 (2014)	Substantially equivalent
Conformance to ISO, IEC,EN, CISPR, ASTM standardslisted below.
Not reported for predicate bymanufacturer	Conformance to standards listedin table below.	Substantially equivalent

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Testing: Testing showed the DizzyDoctor® System 1.0.0 to be in compliance with standards listed in the table. Quality System Management approaches were employed in the development of the DizzyDoctor® System 1.0.0 per 21CFR 820.

Biocompatibility testing was undertaken for Applied Parts of the VRG that may come in contact with a health professional or patient during testing. The DizzyDoctor® System 1.0.0 complied with the following recognized standards, as listed in the table: ISO10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process; ISO10993-5:2009, Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity ISO10993-10:2010; Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization. Additional durability testing of the VRG labels showed them to be resistant to abrasion and peel.

Software verification and validation was undertaken, and documents were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device." The software for this device was considered as a "moderate" level of concern, since a failures or latent design flaws in the software could lead to incorrect or delayed information that could result in non-serious injury of the patient. The device provides no diagnosis, and is one of a battery of tests that are currently used by physicians for vertiginous patients.

Usability/human factors (engineering) testing was performed in three studies. In Study 1, testing of the 30 unique user interface parameters for the DizzyDoctor® System 1.0.0 was performed in 10 subjects who were vertiginous and 10 who were non-vertiginous users. The results revealed that subjects completed the interface tasks competently. Even though two subjects were observed to have difficulty a task at a particular interface, they were able to self-correct and complete the set-up, self-test and after-test activities completely and accurately. In Study 2, methodology similar to that in Study 1 was adopted, and this study extended to two audiologists' evaluations of in-use eye movement recordings and nystagmographs from the DizzyDoctor® System and from the predicate device. The results indicated that

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the audiologists agreed 100% of the time with respect to the presence or absence of pathological nystagmus in the video recordings from the subject and predicate devices. Study 3 was performed in five subjects using similar methodology as in Studies 1 and 2, but aimed at determining whether changes for a software revision might interfere with functions of the user interface. The results indicated that all subjects accomplished the operational tasks. The software revision used in Study 3 was adopted as the production version of the DDS software (i.e., iOS App and Website/Web portal).

Performance, biocompatibility, electrical safety and electromagnetic compatibility (EMC) testing was undertaken on the DizzyDoctor® System 1.0.0, as itemized in the table below, in accordance with the requirements of the design control regulations and established quality assurance procedures. The device passed all testing and conformance standards listed, and represents a low level of residual risk.

Conclusion: The DizzyDoctor® System 1.0.0 Eye Movement Monitor is substantially equivalent to the predicate device.

#	Standard	Name	Date	FDARecog-nition
1	IEC 60601-1:2005+CORR 2006+CORR 2:2007 +AM1:2012	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance.	2012	19-4
2	IEC 60601-1-11	Medical electrical equipment -- Part 1-11: Generalrequirements for basic safety and essentialperformance -- Collateral standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment.	2015	19-6
3	IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and tests.	2014	19-8
4	CISPR11:2009+A1:2010	Industrial, scientific and medical (ism) radiofrequency equipment - radio disturbancecharacteristics - limits and methods ofmeasurement.	2009	No
5	IEC 61000-4-2:2008	Electromagnetic compatibility - testing andmeasurement techniques - electrostatic dischargeimmunity test.	2008	No
6	IEC 61000-4-3:2006A1:2007 + A2:2010	Electromagnetic compatibility - testing andmeasurement techniques -radiated radio frequencyelectromagnetic field immunity test.	2006	No
7	IEC 61000-4-4:2011	Electromagnetic compatibility - testing andmeasurement techniques - electrical fast transient /burst immunity.	2011	No
8	IEC 61000-4-5:2005	Electromagnetic compatibility - testing andmeasurement techniques - surge immunity test.	2005	No
9	IEC 61000-4-6:2003+ A1:2004 +A2:2006	Electromagnetic compatibility, testing andmeasurement techniques, conducted radiofrequency electromagnetic field, immunity test.	2003	No
10	IEC 61000-4-8:2009	Electromagnetic compatibility - testing andmeasurement techniques - for power frequencymagnetic field, immunity test.	2009	No
11	IEC 61000-4-11:2004	Electromagnetic compatibility - testing andmeasurement techniques - voltage dips, shortinterruptions and voltage variations immunity tests.	2004	No
12	ISO 10993-1	Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk ManagementProcess. (Biocompatibility)	2009	2-156
13	ISO 10993-5	Biological evaluation of medical devices - part 5:tests for in vitro cytotoxicity.	2009	2-153
14	ISO 10993-10	Biological evaluation of medical devices - part 10:tests for irritation and skin sensitization.	2010	2-173
15	ASTM D903	Standard Test Method for Peel or StrippingStrength of Adhesive Bonds.	2010	5-42
16	ASTM D1319	Standard Test Method for Hydrocarbon Types inLiquid Petroleum Products by Fluorescent IndicatorAdsorption, as modified Crock Test - Dry Rub &Wet Rub	2015	No
17	ASTM 5135	Standard Test Method for Analysis of Styrene byCapillary Gas Chromatography.	2016	No
18	IEC 61000-4-28	Electromagnetic compatibility (EMC) - Part 4-28:Testing and measurement techniques - Variation ofpower frequency, immunity test for equipment withinput current not exceeding 16 A per phase.	2009	No
19	ISO 14971:2007	Medical devices - Application of risk managementto medical devices.	2007	5-40
20	ISO 15223	BS EN ISO 15223-1: 2016. Medical devices—Symbols to be used with medical device labels,labeling and information to be supplied. Part 1:General requirements, ISO 7000 Reg. No. 1641.	2016	5-117
21	EN 50419	BS EN 50419:2006. Marking of electrical andelectronic equipment in accordance with Article11(2) of Directive 2002/96/EC (WEEE).	2002	No
22	ANSI S3.45-2009(Reaffirmed 2014)	American National Standard Procedures for TestingBasic Vestibular Function. (Dental/ENT):Positioning and Positional Nystagmus.	2014	4-185
END OF DOCUMENTvf_06012018

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vf_06012018

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).