The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Engine.
| Device ID | K011834 |
| 510k Number | K011834 |
| Device Name: | BIS ENGINE |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
| Contact | Christine M Vozella |
| Correspondent | Christine M Vozella ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
| Product Code | OLW |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2001-07-10 |
| Summary: | summary |