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 Full-Montage Standard Electroencephalograph
510(k) Number K934670
Device Name DG 3P SYSTEM
Applicant
Medelec , Ltd.
Manor Way
Old Woking, Surrey,  DE GU22 9JU
Applicant Contact J B HALLOWAY
Correspondent
Medelec , Ltd.
Manor Way
Old Woking, Surrey,  DE GU22 9JU
Correspondent Contact J B HALLOWAY
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received09/29/1993
Decision Date 05/25/1994
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
-
-