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 K023459
Device Name DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Applicant Contact JOEL KENT
Correspondent
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
GXY   OMC   ORT  
Date Received10/15/2002
Decision Date 01/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-