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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521533103 | K072286 | 000 |
| 10884521129832 | K072286 | 000 |
| 10884521130074 | K072286 | 000 |
| 10884521130098 | K072286 | 000 |
| 10884521130173 | K072286 | 000 |
| 10884521130180 | K072286 | 000 |
| 10884521130197 | K072286 | 000 |
| 10884521130210 | K072286 | 000 |
| 10884521130234 | K072286 | 000 |
| 10884521129825 | K072286 | 000 |
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| 10884521129528 | K072286 | 000 |
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| 10884521157538 | K072286 | 000 |
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| 10884521170261 | K072286 | 000 |
| 10884521170278 | K072286 | 000 |
| 10884521186064 | K072286 | 000 |
| 10884521553170 | K072286 | 000 |
| 90884521657515 | K072286 | 000 |