510(k) K173765 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Surveyor Patient Monitor
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 4, 2018 |
| Received | Dec 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2021 | Welch Allyn Inc Mortara Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric po Terminated |
DPS | None listed |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW.
The Surveyor S12 patient monitor Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.