The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Eeg Monitor, Model A-3000.
Device ID | K052362 |
510k Number | K052362 |
Device Name: | BIS EEG MONITOR, MODEL A-3000 |
Classification | Index-generating Electroencephalograph Software |
Applicant | ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
Contact | Christine Vozella |
Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
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 | Yes |
Combination Product | No |
Date Received | 2005-08-29 |
Decision Date | 2005-09-09 |
Summary: | summary |