510(k) K012206 ยท DQK Computer, Diagnostic, Programmable
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
| Applicant | Cambridge Heart, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Oct 12, 2001 |
| Received | Jul 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012206
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.