510(k) K043075 ยท HGM System, Monitoring, Perinatal
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
| Applicant | Tenacore Holdings, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Aug 18, 2005 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043075
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.