K240929 is an FDA 510(k) clearance for the Sleep Apnea Notification Feature (SANF). 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 Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 13, 2024, 162 days after receiving the submission on April 4, 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 | K240929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2024 |
| Decision Date | September 13, 2024 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| 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. |