510(k) K160685 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Surveyor S4 Mobile Monitor
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 4, 2016 |
| Received | Mar 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AH Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.