The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Cerebral Function Monitor 870.
| Device ID | K791580 |
| 510k Number | K791580 |
| Device Name: | CEREBRAL FUNCTION MONITOR 870 |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-17 |
| Decision Date | 1979-09-04 |