The following data is part of a premarket notification filed by Dade Medical, Inc. with the FDA for Meurometrics Monitor.
| Device ID | K803233 |
| 510k Number | K803233 |
| Device Name: | MEUROMETRICS MONITOR |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | DADE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-22 |
| Decision Date | 1981-01-12 |