510(k) K813458 ยท HGM System, Monitoring, Perinatal
FETASCAN 1000, 1000A OBSTETRICAL DATA
| Applicant | Cranbury Medical Labs, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 28, 1982 |
| Received | Dec 10, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813458
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.