510(k) K111745 ยท DSH Recorder, Magnetic Tape, Medical
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
| Applicant | Card Guard Scientific Survival , Ltd., Lakewood CO, US |
| Decision | Substantially Equivalent, Aug 1, 2011 |
| Received | Jun 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111745
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.