510(k) K003492 ยท DQK Computer, Diagnostic, Programmable
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS
| Applicant | Cambridge Heart, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Jan 18, 2001 |
| Received | Nov 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003492
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.