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 K070608
Device Name SMARTEP, MODEL M010000
Applicant
Intelligent Hearing Systems
6860 SW 81st St.
Miami,  FL  33143
Applicant Contact EDWARD MISKIEL
Correspondent
Intelligent Hearing Systems
6860 SW 81st St.
Miami,  FL  33143
Correspondent Contact EDWARD MISKIEL
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Codes
ETN   GWE   GWF  
Date Received03/05/2007
Decision Date 07/18/2007
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
-
-