510(k) K013564 ยท DPS Electrocardiograph
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
| Applicant | Cambridge Heart, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Nov 21, 2001 |
| Received | Oct 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013564
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.