510(k) K111180 ยท DSH Recorder, Magnetic Tape, Medical
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
| Applicant | Vasomedical, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Jun 28, 2011 |
| Received | Apr 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111180
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.