510(k) K000068 ยท OLT Non-Normalizing Quantitative Electroencephalograph Software
COMPUMEDICS E-SERIES EEG SYSTEM
| Applicant | Compumedics Neuro Science Pty , Ltd., Findley MN, US |
| Decision | Substantially Equivalent, Mar 13, 2000 |
| Received | Jan 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2005 | Compumedics Usa, Ltd Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia Terminated |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.