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 K030267
Device Name EEG MONITOR WITH BIS, MODEL A-2000
Applicant
Aspect Medical Systems, Inc.
141 Needham St.
Newton,  MA  02464
Applicant Contact CHRISTINE VOZELLA
Correspondent
Aspect Medical Systems, Inc.
141 Needham St.
Newton,  MA  02464
Correspondent Contact CHRISTINE VOZELLA
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received01/27/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-