510(k) K083820 ยท DSH Recorder, Magnetic Tape, Medical
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
| Applicant | Vasomedical, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Apr 1, 2009 |
| Received | Dec 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083820
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.