510(k) K150620 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
740 SELECT
| Applicant | Cas Medical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, May 8, 2015 |
| Received | Mar 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2024 | Zoe Medical Incorporated Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331 Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.