510(k) K915159 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
PEDIATRIC MULTI-FUNCTION ELECTRODES
| Applicant | Zmi Corp., Woburn MA, US |
| Decision | Substantially Equivalent, Feb 7, 1992 |
| Received | Nov 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2004 | Bio-Detek, Inc. Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode
part Number: 8900-2065 Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.