510(k) K960676 ยท DTE Pulse-Generator, Pacemaker, External
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
| Applicant | Zoll Medical Corp, Burlington MA, US |
| Decision | Substantially Equivalent, Jun 5, 1996 |
| Received | Feb 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | Bio-Detek, Inc. ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) Terminated |
DTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.