510(k) K201635 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MouthLab Vital Signs Monitoring System
| Applicant | Multisensor Diagnostics (Dba Aidar Health), Pikesville MD, US |
| Decision | Substantially Equivalent, Feb 6, 2021 |
| Received | Jun 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201635
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.