510(k) K992706 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
GALIX GBI -3S-LP
| Applicant | Galix Biomedical Instrumentation, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Mar 15, 2001 |
| Received | Aug 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992706
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.