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 normalizing quantitative electroencephalograph software
510(k) Number K041263
FOIA Releasable 510(k) K041263
Device Name NEUROGUIDE ANALYSIS SYSTEM
Applicant
APPLIED NEUROSCIENCE INC.
228 176TH TERRACE DRIVE
ST. PETERSBURG,  FL  33708
Applicant Contact ROBERT W THATCHER
Correspondent
APPLIED NEUROSCIENCE INC.
228 176TH TERRACE DRIVE
ST. PETERSBURG,  FL  33708
Correspondent Contact ROBERT W THATCHER
Regulation Number882.1400
Classification Product Code
OLU  
Date Received05/11/2004
Decision Date 08/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-