Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name index-generating electroencephalograph software
510(k) Number K031694
Device Name MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
Applicant
ASPECT MEDICAL SYSTEMS, INC.
1775 ROCKIES COURT
LAFAYETTE,  CO  80026
Applicant Contact CHRISTINE VOZELLA
Correspondent
ASPECT MEDICAL SYSTEMS, INC.
1775 ROCKIES COURT
LAFAYETTE,  CO  80026
Correspondent Contact CHRISTINE VOZELLA
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received06/02/2003
Decision Date 08/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-