510(k) K243146 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
iCare APP
| Applicant | Ihealth Labs, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 3, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243146
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.