The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Spectral Eeg Monitor Model A1000.
| Device ID | K923043 |
| 510k Number | K923043 |
| Device Name: | SPECTRAL EEG MONITOR MODEL A1000 |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 770 COCHITUATE RD. P.O. BOX 9331 Framingham, MA 01701 |
| Contact | Paul J Manberg |
| Correspondent | Paul J Manberg ASPECT MEDICAL SYSTEMS, INC. 770 COCHITUATE RD. P.O. BOX 9331 Framingham, MA 01701 |
| Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-24 |
| Decision Date | 1992-12-03 |