510(k) K982635 ยท JAF Monitor, Ultrasonic, Nonfetal
CAREDOP II
| Applicant | Nicolet Biomedical, Golden CO, US |
| Decision | Substantially Equivalent, Aug 7, 1998 |
| Received | Jul 13, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surg Terminated |
JAF | None listed |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, et Terminated |
JAF | None listed |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. Terminated |
JAF | None listed |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. Terminated |
JAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.