510(k) K891997 ยท HFM Monitor, Uterine Contraction, External (For Use In Clinic)
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER
| Applicant | Corometrics Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Jun 8, 1989 |
| Received | Mar 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891997
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.