510(k) K050896 ยท DSH Recorder, Magnetic Tape, Medical
H12+ HOLTER RECORDER
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 24, 2005 |
| Received | Apr 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA H12+ and patient cable for the H12+ Holter Recorders 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 10 Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.