Who is the manufacturer of Noxturnal Web?

Nox Medical Ehf filed the 510(k) submission for Noxturnal Web (K241288).

What is the FDA product code for Noxturnal Web?

OLV. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Noxturnal Web?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Noxturnal Web?

SOMNOscreen plus (K201054); SomnoMetry (K221179).

Who can help prepare an FDA 510(k) submission like Noxturnal Web?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Noxturnal Web

K241288 · Nox Medical Ehf · OLV · Dec 23, 2024 · Neurology

Device Facts

Record ID	K241288
Device Name	Noxturnal Web
Applicant	Nox Medical Ehf
Product Code	OLV · Neurology
Decision Date	Dec 23, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Noxturnal Web is indicated for use in the displaying, analysis and printing of pre-recorded biophysical parameters acquired during sleep for the purpose of assisting in the diagnosis of sleep and respiratory-related sleep disorders. Noxturnal Web is intended to be used as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only.

Device Story

Noxturnal Web is a web-based SaMD for reviewing and manually scoring pre-recorded sleep study data. Users (trained medical professionals) access cloud-stored physiological signals (EEG, EOG, EMG, ECG, airflow, respiratory effort, oxygen saturation, body position) via secure credentials. The software provides visualization layouts (e.g., Study Overview, Respiratory Signal Sheet) for manual annotation of sleep stages and respiratory/sleep events. It calculates AASM-standardized indices (e.g., AHI) and generates reports for physician review. Used in clinical environments, it assists physicians in diagnosing sleep and respiratory-related sleep disorders in adults. It does not record signals itself; it functions as a post-acquisition analysis tool. The output supports clinical decision-making by providing organized, scored data and standardized reports, facilitating accurate diagnosis and treatment follow-up.

Clinical Evidence

No clinical data were relied upon for a determination of substantial equivalence. Evidence consists of bench testing, software verification, and validation testing performed in accordance with recognized standards (e.g., IEC 62304, ISO 14971).

Technological Characteristics

Web-based SaMD; cloud-hosted; no hardware components. Processes physiological signals (EEG, EOG, EMG, ECG, airflow, respiratory effort, SpO2, position). Supports manual scoring per AASM guidelines. Connectivity: Networked/Cloud. Standards: IEC 62304, ISO 14971, ANSI AAMI SW96, ISO 20417, AAMI TIR57, IEC 62366-1.

Indications for Use

Indicated for diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. Used under clinician supervision in a clinical environment to analyze physiological signals and manually score sleep study results, including sleep staging, AHI, and detection of sleep-disordered breathing events (e.g., obstructive apneas).

Regulatory Classification

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.

Predicate Devices

SOMNOscreen plus (K201054)
SomnoMetry (K221179)

Reference Devices

Nox Sleep System (K192469)

Related Devices

K260585 — Noxturnal Web · Nox Medical Ehf · Mar 20, 2026
K253668 — Onera SleepMap (SLEEPMAP) · Onera B.V. · Mar 8, 2026
K252330 — DeepRESP · Nox Medical Ehf · Nov 17, 2025
K210034 — EnsoSleep · Ensodata, Inc. · Jun 16, 2021
K241960 — DeepRESP · Nox Medical Ehf · Mar 14, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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. December 23, 2024 Nox Medical ehf % Hrishikesh Gadagkar Senior Principal ROM+ 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146 Re: K241288 Trade/Device Name: Noxturnal Web Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV Dated: May 7, 2024 Received: May 7, 2024 Dear Hrishikesh Gadagkar: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Patrick Antkowiak -S for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K241288 Device Name Noxturnal Web Indications for Use (Describe) Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary Noxturnal Web (K241288) — Traditional 510(k) TEMP-0140 Controlled Document Template 04 {5}------------------------------------------------ 510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02 ### 510(k) Summary ### APPLICANT INFORMATION Company: Nox Medical ehf Katrinartuni 2, IS - 105 Reykjavik, Iceland Telephone: +354 570 7170 Establishment Registration Number: 3007389703 Contact Person: Kolbrun E Ottosdottir Chief Compliance Officer Katrinartuni 2, IS-105 Reykjavik, Iceland November 21, 2024 #### OFFICIAL CORRESPONDENT/CONSULTANT INFORMATION Dr. Hrishikesh Gadagkar, Sr. Principal ROM+ 2790 Mosside Blvd #800, Monroeville, PA 15146 United States Telephone: +1 (410) 245-0501 #### PREPARATION DATE #### DEVICE INFORMATION Device Proprietary Name/Trade Name: Device Classification Name: Regulation Number: Classification: Classification Product Code: 510k Review Panel: Noxturnal Web Standard Polysomnograph with Electroencephalograph 21 CFR 882.1400 Class II OLV Neurology #### PREDICATE DEVICE IDENTIFICATION Substantial equivalence is claimed to: Primary Predicate Device Somnomedics GmbH, SOMNOscreen plus, K201054 Additional Predicate Device Neumetry Medical Inc, SomnoMetry, K221179 Nox Medical, Nox Sleep System, K192469 Reference Device All predicate and reference devices have not been subject to a design-related recall. {6}------------------------------------------------ 510(k) Summary Noxturnal Web — Traditional 510(k) #### DEVICE DESCRIPTION Noxturnal Web is a web-based software that can be utilized to screen various sleep and respiratoryrelated sleep disorders. The users of Noxturnal Web are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. Users can input a sleep study recording stored on the cloud (electronic medical record repository) using their established credentials. Once the sleep study data has been retrieved, the Noxturnal Web software can be used to display, manually analyze, generate reports and print the prerecorded physiological signals. Noxturnal Web is used to read sleep study data for the display, analysis, summarization, and retrieval of physiological parameters recorded during sleep and awake. Noxturnal Web facilitates a user to review or manually score a sleep study either before the initiation of treatment or during the treatment follow-up for various sleep and respiratory-related sleep disorders. Noxturnal Web presents information from the input sleep study data in an organized layout. Multiple visualization layouts (e.g., Study Overview, Respiratory Signal Sheet, etc.) are available to allow the users to optimize the visualization of key data components. The reports generated by Noxturnal Web allow the inclusion of custom user comments, and these reports can then be viewed on the screen and/or printed. #### INTENDED USE Noxturnal Web is indicated for use in the displaying, analysis and printing of pre-recorded biophysical parameters acquired during sleep for the purpose of assisting in the diagnosis of sleep and respiratoryrelated sleep disorders. Noxturnal Web is intended to be used as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. #### INDICATIONS FOR USE Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Nox Medical believes that the Noxturnal Web is substantially equivalent to the predicate devices SOMNOscreen plus (K201054) and SomnoMetry (K221179) based on the information summarized here: - . The subject device has the same intended use as the predicate devices cleared in K201054 and K221179, i.e., a software intended to analyze pre-recorded physiological data acquired during sleep and derive actionable clinical insights. - . The subject device and the predicates are intended to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders by supporting the display, analysis, summary, and retrieval of physiological parameters already recorded by sleep recording devices/systems. The devices use the same basic data inputs to be analyzed as part of the manual scoring process including sleep staging and marking of respiratory (e.g. apnea and hypopnea) and sleep events (e.g. arousal and leg movements) and do calculate the American Academy of Sleep Medicine (AASM) standardized indices (e.g. AHI) and support report generation. - . The primary predicate device, SOMNOscreen plus (K201054), is a portable physiological signal recording system supporting manual scoring of sleep studies. The subject device, Noxturnal Web (K241288), is Software as a Medical Device (SaMD) and does not include the functionality of recording physiological signals. The substantial equivalence is being drawn to the software portion of SOMNOscreen plus, DOMINO, which is used as a tool to display, analyze, and print the physiological signals recorded by the recording device. Both Noxturnal Web and DOMINO {7}------------------------------------------------ 510(k) Summary Noxturnal Web – Traditional 510(k) Document Number: REG-0005 Revision Number: 02 provide a manual scoring workflow for interpreting data recorded by systems (e.g., PSG signals). Both systems rely on manual scoring for sleep stages including sleep stages W, N1/N2/N3, and REM, and sleep and respiratory events. Regarding the data inputs and outputs, both the subject device and the primary predicate device have similarities in the types of physiological signals processed, such as EEG, EOG, EMG, ECG, oxygen saturation, airflow and respiratory effort, and both systems support calculation of AASM standardized indices and generate sleep study reports. Based on the detailed comparison of the workflow, appearance, function, indexes calculated and reporting, it has been demonstrated that the technological characteristics relating to the manual annotation/scoring process of sleep study data may be considered the same or substantially equivalent for the subject device and the primary predicate (K201054). - . The subject device and additional predicate (K221179) are Web-based software operating in the cloud. Both the subject device and additional predicate device do not require installation on the user's computer. - . The Nox Sleep System (K192469) has been selected as a reference device to support the technology and scientific methods of the subject device. The backend implementation for the subject device is identical to the corresponding qualitative and quantitative functionality implemented in the reference device. Nox Medical has implemented cybersecurity controls for Noxturnal Web and Nox Sleep System to assure the medical device cybersecurity and to maintain medical device functionality, safety, and effectiveness. The assessment was performed in accordance with FDA's Guidance "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". {8}------------------------------------------------ 510(k) Summary Noxturnal Web – Traditional 510(k) | Trade/Device Name | Subiect Device: Noxturnal Web (K241288) | Primary Predicate Device: SOMNOscreen plus (K201054) | Additional Predicate Device: SomnoMetry (K221179) | Reference Device: Nox Sleep System (K192469) | Comparison of Subject, Predicates, and Reference Device | | |---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Description | | | | | | | | Manufacturer | Nox Medical | Somnomedics GmbH | Neumetry Medical, Inc. | Nox Medical | N/A | | | 510(k) Number | K241288 | K201054 | K221179 | K192469 | N/A | | | Regulation Description | 21 CFR 882.1400 | 21 CFR 882.1400 | 21 CFR 882.1400 | 21 CFR 882.1400 | Same. | | | Regulation Name | Electroencephalograph | Electroencephalograph | Electroencephalograph | Electroencephalograph | Same. | | | Regulatory Class | Class II | Class II | Class II | Class II | Same. | | | Product Code(s) | OLV | Main: OLV; Sub: MNR | OLZ | Main: OLZ; Sub: KZM | Same as primary predicate. | | | Comparison of Intended and Indications of Use | | | | | | | | Intended Use | Noxturnal Web is indicated for use in the displaying, analysis and printing of pre-recorded biophysical parameters acquired during sleep for the purpose of assisting in the diagnosis of sleep and respiratory-related sleep disorders. Noxturnal Web is intended to be used as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. | The SOMNOscreen® plus is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders. The device is a non- life-supporting physiological signal recording device intended to be used for studies testing adults and children/adolescents suspected of having sleep-related breathing disorders. This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers. | Analyze pre-recorded physiological data acquired during sleep and derive actionable clinical insights. | The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre- defined reports based on subject's data. | Same. Noxturnal Web, as well as the predicate devices, is indicated for use in the displaying, analysis and printing of pre- recorded biophysical parameters for the purpose of assisting in the diagnosis of sleep and respiratory-related sleep disorders. The intended population of the subject device, Noxturnal Web is limited to adults only, thereby aligning with the indications for use of the identified primary predicate device, SOMNOscreen plus (K201054) and additional predicate device, SomnoMetry (K221179). | | | Trade/Device Name | Subject Device: Noxturnal Web (K241288) | Primary Predicate Device: SOMNOscreen plus (K201054) | Additional Predicate Device: SomnoMetry (K221179) | Reference Device: Nox Sleep System (K192469) | Comparison of Subject, Predicates, and Reference Device | | | | | | | The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home. | | | | Indications for Use | Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. Noxturnal Web is a software- only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. | The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sleep-related breathing disorders. | SomnoMetry is intended for use for diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. SomnoMetry plus is a software-only medical device to be used to analyze physiological signals and automatically score sleep study results, including the staging of sleep, AHI, and detection of sleep-disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. All automatically scored events are subject to verification by a qualified clinician. | The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre- | The primary predicate device includes hardware that is used to record the physiological signals. The subject device does not contain any hardware / recording function. This difference does not raise any concerns of safety or effectiveness. The primary predicate device contains software, DOMINO, that is used for display, analysis, and printing of the physiological signals recorded by the SOMNOscreen plus. Same target patient population. The intended population of the subject device, Noxturnal Web, is limited to adults only, thereby aligning with the indications for use of the | | | | | | | | | | | Trade/Device Name | Subject Device: Noxturnal Web (K241288) | Primary Predicate Device: SOMNOscreen plus (K201054) | Additional Predicate Device: SomnoMetry (K221179) | Reference Device: Nox Sleep System (K192469) | Comparison of Subject, Predicates, and Reference Device | | | | | | | defined reports based on subject's data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home. | identified primary predicate device, SOMNOscreen plus (K201054) and additional predicate device, SomnoMetry (K221179). Same intended use. The subject and predicate devices are intended to be used as an aid for the diagnosis of sleep and respiratory-related sleep disorders. | | | Environment of Use | Clinical Environment | Clinical Environment | Clinical Environment | Clinical Environment / Home Environment | Same. | | | Target Users | Medical Professionals | Medical Professionals | Medical Professionals | Medical Professionals | Same. | | | Target Patient Population | Adults only | General Population (adults and children/adolescents) | Adults only…