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 K052145
Device Name DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
Applicant
Ge Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL KENT
Correspondent
Ge Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
MHX   MLD   OMC   ORT  
Date Received08/08/2005
Decision Date 08/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-