510(k) K991054 ยท GWQ Full-Montage Standard Electroencephalograph
BRAVO MULTI-MODALITY SYSTEM
| Applicant | Nicolet Biomedical, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Nov 3, 1999 |
| Received | Mar 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2010 | CareFusion NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711. Terminated |
GWQ | None listed |
| Sep 23, 2008 | Cardinal Health NeuroCare Division NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The s Terminated |
GWQ | None listed |
| Sep 21, 2008 | Cardinal Health NeuroCare Division NicoletOne photic adapter cable 085-463700 Terminated |
GWQ | None listed |
| Feb 15, 2007 | Nicolet Biomedical Div of Viasys Healthcare NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems. Terminated |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.