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 Stimulator, Auditory, Evoked Response
510(k) Number K012415
Device Name AURIS AEP
Applicant
SYNAPSYS, INC.
150-10 132 AVE.
JAMAICA,  NY  11434
Applicant Contact JULIEN CHAUSSY
Correspondent
SYNAPSYS, INC.
150-10 132 AVE.
JAMAICA,  NY  11434
Correspondent Contact JULIEN CHAUSSY
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received07/30/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-