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 |