510(k) K883334 ยท HEK Monitor, Heart Sound, Fetal, Ultrasonic
BIODOP(TM)
| Applicant | Diagnosis Related Systems, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Dec 15, 1988 |
| Received | Aug 9, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883334
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.