The following data is part of a premarket notification filed by Compumedics Neuro Science Pty Ltd. with the FDA for Compumedics E-series Eeg System.
| Device ID | K000068 |
| 510k Number | K000068 |
| Device Name: | COMPUMEDICS E-SERIES EEG SYSTEM |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | COMPUMEDICS NEURO SCIENCE PTY LTD. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy COMPUMEDICS NEURO SCIENCE PTY LTD. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-10 |
| Decision Date | 2000-03-13 |