510(k) K221056 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ARGUS PB-3000
| Applicant | Schiller AG, Baar, CH |
| Decision | Substantially Equivalent, Jul 6, 2023 |
| Received | Apr 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2025 | Schiller, Ag Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.