510(k) K895729 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
R2 PACE PAD, MODEL 480
| Applicant | Darox Corp., Niles IL, US |
| Decision | Substantially Equivalent, Oct 12, 1989 |
| Received | Sep 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895729
| 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 pediatrics. Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.