510(k) K871385 ยท HGM System, Monitoring, Perinatal
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
| Applicant | Fukuda Denshi USA, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, May 26, 1987 |
| Received | Apr 7, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871385
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.