DEN230041 is an FDA 510(k) submission for the Sleep Apnea Feature. This device is classified as a Over-the-counter Device To Assess Risk Of Sleep Apnea (Class II - Special Controls, product code QZW).
Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Not Cleared (DENG) decision on February 6, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2378. An Over-the-counter Device To Assess Risk Of Sleep Apnea Is Intended To Provide A Notification Of The Risk Of Sleep Apnea In Users Who Have Not Been Previously Diagnosed With Sleep Apnea. This Device Uses Software Algorithms To Analyze Input Sensor Signals And Provide A Risk Assessment For Sleep Apnea. It Is Not Intended To Provide A Standalone Diagnosis, Replace Traditional Methods Of Diagnosis (e.g., Polysomnography), Assist Clinicians In Diagnosing Sleep Disorders, Or Be Used As An Apnea Monitor..
| 510(k) Number | DEN230041 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 31, 2023 |
| Decision Date | February 06, 2024 |
| Days to Decision | 251 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | QZW — Over-the-counter Device To Assess Risk Of Sleep Apnea |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2378 |
| Definition | An Over-the-counter Device To Assess Risk Of Sleep Apnea Is Intended To Provide A Notification Of The Risk Of Sleep Apnea In Users Who Have Not Been Previously Diagnosed With Sleep Apnea. This Device Uses Software Algorithms To Analyze Input Sensor Signals And Provide A Risk Assessment For Sleep Apnea. It Is Not Intended To Provide A Standalone Diagnosis, Replace Traditional Methods Of Diagnosis (e.g., Polysomnography), Assist Clinicians In Diagnosing Sleep Disorders, Or Be Used As An Apnea Monitor. |