510(k) K123556 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MORTARA SURVEYOR PATIENT MONITOR
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Mar 22, 2013 |
| Received | Nov 19, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K123556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2014 | Mortara Instrument, Inc Mortara Surveyor S12 and Surveyor S19 Patient Monitors.
Product Usage:
They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood press Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.