510(k) K033048 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
| Applicant | Cas Medical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Jun 1, 2004 |
| Received | Sep 29, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | CAS Medical Systems, Inc. 740 Series Multiparameter Monitor Software Version 3.0
Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.