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 Electrode, Cortical
510(k) Number K924226
Device Name OJEMANN CORTICAL STIMULATOR
Applicant
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Applicant Contact LINDA JALBERT
Correspondent
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Correspondent Contact LINDA JALBERT
Regulation Number882.1310
Classification Product Code
GYC  
Date Received08/21/1992
Decision Date 04/21/1993
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
Recalls CDRH Recalls
-
-