510(k) K021185 ยท OLV Standard Polysomnograph With Electroencephalograph
NERVUS MONITOR
| Applicant | Taugagreining HF, Crofton MD, US |
| Decision | Substantially Equivalent, Jul 12, 2002 |
| Received | Apr 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2018 | Natus Neurology Inc Nicolet Ambulatory EEG Terminated |
OLV | None listed |
| Jan 3, 2008 | Nicolet Biomedical Div of Viasys Healthcare Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Terminated |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.