510(k) K011304 ยท HGM System, Monitoring, Perinatal
OB-1 FETAL MONITOR
| Applicant | Analogic Corp., Wakefield MA, US |
| Decision | Substantially Equivalent, May 29, 2001 |
| Received | Apr 30, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011304
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.