The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Cerebral Tracer 1500 & Ct 1.0 Software.
| Device ID | K844015 |
| 510k Number | K844015 |
| Device Name: | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | CNS, INC. 7090 SHADY OAK RD. Eden Prairie, MN 55344 |
| Contact | Ronald Podraza |
| Correspondent | Ronald Podraza CNS, INC. 7090 SHADY OAK RD. Eden Prairie, MN 55344 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-12 |
| Decision Date | 1984-12-17 |