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, Photic, Evoked Response
510(k) Number K932571
Device Name TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
Applicant
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Applicant Contact LORI TRUITT
Correspondent
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Correspondent Contact LORI TRUITT
Regulation Number882.1890
Classification Product Code
GWE  
Date Received05/27/1993
Decision Date 08/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-