The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Eeg Vista Monitor System And Bisx.
| Device ID | K072286 |
| 510k Number | K072286 |
| Device Name: | BIS EEG VISTA MONITOR SYSTEM AND BISX |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 1 UPLAND ROAD Norwood, MA 02062 |
| Contact | Vikram Verma |
| Correspondent | Vikram Verma ASPECT MEDICAL SYSTEMS, INC. 1 UPLAND ROAD Norwood, MA 02062 |
| 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 | 2007-08-16 |
| Decision Date | 2007-11-20 |
| Summary: | summary |