510(k) K002158 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
| Applicant | Datex-Ohmeda, Inc., Tewksburt MA, US |
| Decision | Substantially Equivalent, Sep 6, 2000 |
| Received | Jul 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002158
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.