510(k) K153475 ยท KNG Monitor, Ultrasonic, Fetal
SD5 & SD6 Ultrasonic Tabletop Doppler
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 29, 2016 |
| Received | Dec 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153475
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.