510(k) K883523 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
| Applicant | Cardiotronics, Inc., West Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 6, 1988 |
| Received | Aug 17, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883523
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.