The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for A-1000 Eeg Monitor And A-1050 Eeg Monitor.
| Device ID | K963644 |
| 510k Number | K963644 |
| Device Name: | A-1000 EEG MONITOR AND A-1050 EEG MONITOR |
| 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 | 1996-09-12 |
| Decision Date | 1996-10-08 |
| Summary: | summary |