510(k) K200160 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
740 SafeSAT
| Applicant | Zoe Medical, Inc., Topsfield MA, US |
| Decision | Substantially Equivalent, Feb 15, 2021 |
| Received | Jan 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200160
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.