510(k) K033030 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
| Applicant | Witt Biomedical Corp, Melbourne FL, US |
| Decision | Substantially Equivalent, Feb 24, 2004 |
| Received | Sep 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2005 | Witt Biomedical Corporation Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.