510(k) K901643 ยท HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
ISOFLO(TM) AMNIOCENTESIS TRAY
| Applicant | Healthdyne Cardiovascular, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 25, 1990 |
| Received | Apr 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901643
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.