Samsung Sleep Apnea Feature (Wear OS)

Primary DI
08806094936872
Brand
Samsung Sleep Apnea Feature (Wear OS)
Company
Samsung Electronics Co., Ltd.
Model
1.X
Device description
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Published
2025-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QZWOver-The-Counter Device To Assess Risk Of Sleep Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZWOver-The-Counter Device To Assess Risk Of Sleep ApneaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230041000Sleep Apnea FeatureSamsung Electronics Co., Ltd.2024-02-06QZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806094936872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806094936872088060949368728806094936872

GMDN Terms#

Term, Definition table
TermDefinition
Patient general health self-management softwareAn Internet-based software program intended to be used on a non-medical computerized device, by a patient in a non-clinical environment, to provide general health assessment information and/or health advice through an interactive platform; it is not dedicated to a specific condition. The software is intended to collect patient information (demographics, lifestyle data, and/or symptoms) and feedback information to indicate the general health/wellness in key areas (e.g., mental, cardiovascular) and/or assist the patient in deciding the best course of action if they are unwell (e.g., see a clinician, self-treatment for minor ailments). It does not communicate with a clinician.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687967554
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806092938823ECG Monitor Appv1.12021-08-25
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094948233Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806090792021ECG Monitor Appv1.12020-09-24
08806090792045ECG Monitor Appv1.12020-09-24
08801643467098NAAuto Lung Nodule Detection2026-03-17
08806088565231NAGC85A2016-09-24
08806088582412NAGM852016-11-26
08806088773797NAGR40CW2019-06-19
08806094936889Samsung Sleep Apnea Feature (Android OS)1.X2025-02-24
08806092938854Samsung Health Body Composition1.x2021-09-07
08806095896144NAF4343-AW2024-11-26
08806095799636NAGF85-3P2024-10-18
08806095799643NAGF85-SP2024-10-18
08806092938847Samsung Health Body Composition1.x2021-09-07
08806094744934NAF4335-AW2022-10-20
08806094458213NAS4335-AWM2022-05-04
08806094458220NAS4343-AWM2022-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806094936889Samsung Sleep Apnea Feature (Android OS)Samsung Electronics Co., Ltd.QZW2025-02-24
00195949116193Sleep Apnea Notification Feature (SANF)APPLE INC.QZW2024-09-18
00195949116209Sleep Apnea Notification Feature (SANF)APPLE INC.QZW2024-09-18