The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Eeg Monitor View.
| Device ID | K062613 |
| 510k Number | K062613 |
| Device Name: | BIS EEG MONITOR VIEW |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. ONE UPLAND ROAD Norwood, MA 02062 |
| Contact | Vikram Verma |
| Correspondent | Vikram Verma ASPECT MEDICAL SYSTEMS, INC. ONE UPLAND ROAD Norwood, MA 02062 |
| 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 | 2006-09-05 |
| Decision Date | 2007-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521130111 | K062613 | 000 |
| 10884521157545 | K062613 | 000 |
| 10884521128774 | K062613 | 000 |
| 10884521175501 | K062613 | 000 |
| 10884521164024 | K062613 | 000 |
| 10884521130067 | K062613 | 000 |
| 10884521164031 | K062613 | 000 |