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 Full-Montage Standard Electroencephalograph
510(k) Number K023771
Device Name SYNAMPS2
Applicant
Neuroscan
7850 Paseo Del Norte
Suite 101
El Paso,  TX  79912
Applicant Contact ELVIRA GARCIA
Correspondent
Neuroscan
7850 Paseo Del Norte
Suite 101
El Paso,  TX  79912
Correspondent Contact ELVIRA GARCIA
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received11/12/2002
Decision Date 02/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-