510(k) K982091 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CS/3 COMPACT AIRWAY MODULE, M-COVX
| Applicant | Datex-Engstrom, Inc., Tewksburt MA, US |
| Decision | Substantially Equivalent, Dec 22, 1998 |
| Received | Jun 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982091
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.