510(k) K935371 ยท DRX Electrode, Electrocardiograph
R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD
| Applicant | R2 Medical Systems, Niles IL, US |
| Decision | Substantially Equivalent, Dec 2, 1994 |
| Received | Nov 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults. Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.