510(k) K012837 ยท MLD Monitor, St Segment With Alarm
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
| Applicant | Datex-Ohmeda, Needham MA, US |
| Decision | Substantially Equivalent, Sep 14, 2001 |
| Received | Aug 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Cardiocap/5 Patient Monitors Terminated |
MHX | None listed |
| Mar 5, 2003 | Datex-Ohmeda Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option Terminated |
DPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.