510(k) K092853 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
| Applicant | Galix Biomedical Instrumentation, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Jul 9, 2010 |
| Received | Sep 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092853
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.