510(k) K253569 ยท NYV Gastrointestinal Motility System, Capsule
Atmo Gas Capsule System
| Applicant | Atmo Biosciences, Ltd., Box Hill, AU |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253569
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.