510(k) K974149 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
AMBULATORY X-12 TELEMETRY MODULE
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 8, 1998 |
| Received | Nov 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LE Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.