510(k) K261011 ยท QZW Over-The-Counter Device To Assess Risk Of Sleep Apnea
Sleep Apnea Feature (v2.0)
| Applicant | Samsung Electronics Co., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, Jul 20, 2026 |
| Received | Mar 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261011
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.