The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for A-2000 Eeg Monitor With Bis.
| Device ID | K974496 |
| 510k Number | K974496 |
| Device Name: | A-2000 EEG MONITOR WITH BIS |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 2 VISION DR. Natick, MA 01760 -2059 |
| Contact | Christine Morgida |
| Correspondent | Christine Morgida ASPECT MEDICAL SYSTEMS, INC. 2 VISION DR. Natick, MA 01760 -2059 |
| Product Code | OLW |
| Subsequent 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 | 1997-11-28 |
| Decision Date | 1998-02-06 |
| Summary: | summary |