• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K052066
Device Name CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
Original Applicant
BIO-LOGIC SYSTEMS CORP.
one bio-logic plaza
mundelein,  IL  60060 3700
Original Contact norman e brunner
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received08/01/2005
Decision Date 08/26/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-