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 K991853
Device Name INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
Applicant
Idem (Int'L Dist. of Electronics For Medicine)
4814 E. Second St.
Benicia,  CA  94510
Applicant Contact DONNA WARD
Correspondent
Idem (Int'L Dist. of Electronics For Medicine)
4814 E. Second St.
Benicia,  CA  94510
Correspondent Contact DONNA WARD
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received06/01/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-