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 K874193
Device Name MICROSHEV MODEL 2000
Applicant
MICRO-SHEV LTD.
CO/TERRIS/EDGECOMBE/HECK/WAYNE
1121 12TH STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact ELLEN K WAYNE
Correspondent
MICRO-SHEV LTD.
CO/TERRIS/EDGECOMBE/HECK/WAYNE
1121 12TH STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact ELLEN K WAYNE
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received10/14/1987
Decision Date 03/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-