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 K781005
Device Name ELECTROENCEPHALOGRAPH ACCUTRATE 200
Applicant
Beckman Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Beckman Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/19/1978
Decision Date 06/28/1978
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
-
-