510(k) K004007 ยท DSH Recorder, Magnetic Tape, Medical
DR180+OXY
| Applicant | North East Monitoring, Inc., Sudbury MA, US |
| Decision | Substantially Equivalent, Jan 25, 2001 |
| Received | Dec 26, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K004007
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.