510(k) K082312 ยท DPS Electrocardiograph
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
| Applicant | Heartscape Technologies, Ltd., Bangor, Co Down, GB |
| Decision | Substantially Equivalent, Sep 12, 2008 |
| Received | Aug 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082312
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.